PSG Cable M
The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG).
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Aimooe Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 1 |
Record
| Listed by | Sentec AG, Switzerland |
|---|---|
| FDA product code | LPP |
| Device type | Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2500 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K041548 |
| Record published | 2018-11-12 |
| Record revised | 2026-03-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PSG Cable M | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PF 6840-4 TC Remote Panel 4 Channels | Perimed AB | 1 |
| PSG Cable C | Sentec AG | 1 |
| PF 6840-2 TC Remote Panel 2 Channels | Perimed AB | 1 |
| Connector kit For ETC hyperbaric chamber | Radiometer Medical APS | 1 |
| PSG Cable A | Sentec AG | 1 |
| O2 module for the TCM4XX Series | Radiometer Medical APS | 1 |
| PSG Cable E | Sentec AG | 1 |
| TC electrode | Radiometer Medical APS | 1 |
| Contact Gel | Sentec AG | 1 |
| Fixation Kit For TC electrodes | Radiometer Medical APS | 1 |
| Isolation Transformer 100-120V | Sentec AG | 1 |
| Multi-Site Attachment Ring for fragile/sensitive skin | Sentec AG | 1 |
Showing 12 of 34. All products under Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
Recalls Naming This Product
14 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Sentec AG | 510(k) number | 2023-07-25 | Class II | Process control | During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance. | REVISED 9/21/2023-15,065 packages | |
| Sentec AG | 510(k) number | 2023-05-02 | Class II | Device Design | The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode “production” and were not reset to “released” mode. | 11 in the U.S. | |
| Sentec AG | 510(k) number | 2022-08-22 | Class II | Under Investigation by firm | Weak skin adhesion. | 17208 units | 2026-05-26 |
| Sentec AG | 510(k) number | 2020-12-10 | Class II | Device Design | Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards. | 15 devices | 2026-08-31 |
| Sentec AG | 510(k) number | 2019-05-02 | Class II | Process control | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. | 198 pcs. | 2020-12-16 |
| Sentec AG | 510(k) number | 2019-05-02 | Class II | Process control | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. | 22 pcs | 2020-12-16 |
| Sentec AG | 510(k) number | 2019-05-02 | Class II | Process control | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. | 10 pcs | 2020-12-16 |
| Sentec AG | 510(k) number | 2019-05-02 | Class II | Process control | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. | 3 sets | 2020-12-16 |
| Sentec AG | 510(k) number | 2019-05-02 | Class II | Process control | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. | 205 pcs | 2020-12-16 |
| Sentec AG | 510(k) number | 2016-09-15 | Class II | Component change control | Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A loose screw within the monitor can create uncontro | 75 (54 US; 21 =OUS) | 2017-06-23 |
| Sentec AG | 510(k) number | 2015-03-25 | Class II | Under Investigation by firm | SenTec is voluntarily replacing V-Sign Sensors 2 due to pre-mature deterioration of a part of the PCO2 measuring unit and thus disabling PCO2-monitoring. This means that the affected sensors reach their end-of-life earlier than normally exp | 129 US, 59 OUS | 2016-02-05 |
| Sentec AG | 510(k) number | 2012-11-05 | Class II | Component design/selection | A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated. | 195 boxes (9 per box) | 2012-12-18 |
| Sentec AG | 510(k) number | 2012-11-05 | Class II | Component design/selection | A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated. | 265 boxes (5 per box) | 2012-12-18 |
| Sentec AG | 510(k) number | 2012-07-09 | Class II | Device Design | SenTec is recalling a number of V-Sign”2 Sensors due to a problem regarding configuration parameter writing during manufacturing. | 8 | 2012-10-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.