Q-Tel RMS
Cardiac and pulmonary rehabilitation data acquisition and editing system
10manufacturers in China registered for this device type
20catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Linxens Healthcare (Tianjin) Co., Ltd. | Jinnan District | Tianjin | Contract manufacturer | 7 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Shandong Corecare Technology Limited | Jinan | Shandong | Manufacturer | 2 |
Record
| Listed by | Mortara Instrument, Inc., United States |
|---|---|
| FDA product code | DSI |
| Device type | Detector And Alarm, Arrhythmia |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| 510(k) | K003576 |
| Record published | 2016-09-24 |
| Record revised | 2023-03-08 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | serial number |
| Storage | Storage environment humidity up to 90 % RH; Storage environment temperature up to 113 °F |
| Distribution end date | 2023-03-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 33193-106-50 | In distribution | |
| 11089-001-70 | In distribution | |
| QTELM-P-AAAA | Withdrawn | |
| QTELS-P-AC | Withdrawn | |
| QTELM-P-ABXX | Withdrawn | |
| QTELM-P-AAAX | Withdrawn | |
| 33193-104-50 | Withdrawn | |
| QTELM-P-ACXX | Withdrawn | |
| QTELM-P-XXXX | Withdrawn | |
| QTELM-P-ACXA | Withdrawn | |
| QTELS-P-XX | Withdrawn | |
| QTELM-P-AAXX | Withdrawn | |
| QTELM-P-AAXA | Withdrawn | |
| QTELM-P-ACAA | Withdrawn | |
| QTELM-P-ABAA | Withdrawn | |
| QTELM-P-ABAX | Withdrawn | |
| QTELM-P-ABXA | Withdrawn | |
| QTELM-P-ACAX | Withdrawn | |
| QTELS-P-AA | Withdrawn | |
| QTELS-P-AB | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trulink | Spacelabs Healthcare (Washington), Inc | 160 |
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 30 |
| Detector And Alarm, Arrhythmia | Philips Medical Systems Hsg | 20 |
| ECG Electrodes | Philips Medical Systems Hsg | 19 |
| Seeq™ | Medtronic, Inc. | 18 |
| Life Sensing Instruments, Inc. | Life Sensing Instruments, Inc. | 17 |
| NIBP Cuffs | Philips Medical Systems Hsg | 14 |
| Waveline EZ+ | Avante | 11 |
| BodyGuardian | Preventice Technologies, Inc. | 10 |
| BodyGuardian Kit | Preventice Technologies, Inc. | 8 |
| Waveline Pro+ | Avante | 7 |
| NIBP Cuffs | Philips Medizin Systeme Böblingen GmbH | 7 |
Showing 12 of 112. All products under Detector And Alarm, Arrhythmia
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K900720 | 1990-11-05 |
| K880664 | 1988-03-09 |
| K851702 | 1985-07-29 |
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.