Guava II
510(k) K122632
Guava II is a Class II device made by CardioComm Solutions, Inc, cleared under FDA 510(k) K122632 on 11 Feb 2014, 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 | FDA 510(k)SESE | NumberK122632 | Date11 Feb 2014 | StatusActive |
Official records
- FDA 510(k) database K122632
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DPS
- FDA applicant
- Cardiocomm Solutions, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2340
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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