Med-Tech Resource CP6321
Med-Tech Resource CP6321 is a Class II device made by Med-Tech Resource, LLC, cleared under FDA 510(k) K210288 on 26 Aug 2021 and listed in FDA GUDID since 2 Jun 2025 (UDI-DI 00850075255023), 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 | Number00850075255023 | Date2 Jun 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK210288 | Date26 Aug 2021 | StatusActive |
Official records
- AccessGUDID record 00850075255023
- FDA 510(k) database K210288
Across registries
- FDA 510(k) K210288 decided 26 Aug 2021 Active
- FDA GUDID UDI-DI 00850075255023 listed 2 Jun 2025 Listed
Timeline
- Cleared FDA 510(k) K210288
- Listed FDA GUDID 00850075255023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Med-Tech Resource
- Generic name
- Pulmonary resuscitator, manual, reusable
- Model / reference
- CP6321
- Primary DI / UDI-DI
- 00850075255023
- 510(k) Number
- FDA product code
- BTM
- GMDN term
- Pulmonary resuscitator, manual, reusable
- Device class
- Class II
- Regulation number
- 868.5915
- GUDID distribution status
- In Commercial Distribution
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