Modification to Globalcardio
510(k) K033037
Modification to Globalcardio is a Class II device made by CardioComm Solutions, Inc, cleared under FDA 510(k) K033037 on 31 Oct 2003, 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 | NumberK033037 | Date31 Oct 2003 | StatusActive |
Official records
- FDA 510(k) database K033037
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DSH
- FDA applicant
- Cardiocomm Solutions, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2800
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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