CardioPAL Savi
CardioPAL SAVI is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Hebei (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC | Shanghai | Shanghai | Specification developer | 6 |
Record
| Listed by | Medicomp, Inc., United States |
|---|---|
| FDA product code | MLO |
| Device type | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2800 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-11-16 |
| Record revised | 2023-09-26 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment temperature -15 to 60 °C; Handling environment humidity 10 to 95 % RH; Handling environment temperature 0 to 45 °C |
| Distribution end date | 2023-09-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PM410 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HScribe | Mortara Instrument, Inc. | 55 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 41 |
| Millennia Software | Braemar Manufacturing, LLC | 18 |
| Patient Cable | Global Instrumentation, LLC | 13 |
| Modality Manager | Mortara Instrument, Inc. | 10 |
| Norav 1200 Series PC-ECG | Norav Medical Inc. | 6 |
| Matrix Holter System | Global Instrumentation, LLC | 5 |
| GI Holter System | Global Instrumentation, LLC | 5 |
| Cardiospy ECG Holter System | Labtech Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság | 4 |
| WA Holter System | Global Instrumentation, LLC | 3 |
| Contec | Contec Medical Systems Co., Ltd. | 3 |
| Scribe | Mortara Instrument, Inc. | 2 |
Showing 12 of 33. All products under Electrocardiograph, Ambulatory, With Analysis Algorithm
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K043454 | 2005-03-24 |
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.