Cardio Clear PH304
by Cardio-Medical Products, Inc.
Cardio Clear PH304 is a Class II device made by Cardio-Medical Products, Inc., cleared under FDA 510(k) K103651 on 4 Oct 2011 and listed in FDA GUDID since 28 Jul 2015 (UDI-DI 00814907020128), active as of 8 Nov 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 | Number00814907020128 | Date28 Jul 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK103651 | Date4 Oct 2011 | StatusActive |
Official records
- AccessGUDID record 00814907020128
- FDA 510(k) database K103651
Across registries
- FDA 510(k) K103651 decided 4 Oct 2011 Active
- FDA GUDID UDI-DI 00814907020128 listed 28 Jul 2015 Listed
Timeline
- Cleared FDA 510(k) K103651
- Listed FDA GUDID 00814907020128
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cardio Clear
- Generic name
- External defibrillation electrode, paediatric, single-use
- Model / Ref / Catalog
- PH304
- Primary DI / UDI-DI
- 00814907020128
- 510(k) Number
- FDA product code
- LDD
- GMDN term
- External defibrillation electrode, paediatric, single-use
- Device class
- Class II
- Regulation number
- 870.5300
- GUDID distribution status
- In Commercial Distribution
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