Contec PM10
by Contec Medical Systems Co., Ltd.
Contec PM10 is a Class II device made by Contec Medical Systems Co., Ltd., cleared under FDA 510(k) K152863 on 22 Jun 2016 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 06945040101505), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06945040101505 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152863 | Date22 Jun 2016 | StatusActive |
Official records
- AccessGUDID record 06945040101505
- FDA 510(k) database K152863
Across registries
- FDA 510(k) K152863 decided 22 Jun 2016 Active
- FDA GUDID UDI-DI 06945040101505 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K152863
- Listed FDA GUDID 06945040101505
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Contec
- Generic name
- Telemetric electrocardiographic ambulatory recorder
- Model / reference
- PM10
- Primary DI / UDI-DI
- 06945040101505
- FDA product code
- DPS
- GMDN term
- Telemetric electrocardiographic ambulatory recorder
- Device class
- Class II
- Regulation number
- 870.2340
- GUDID distribution status
- In Commercial Distribution
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