FRR
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Chamber, Reverse Isolation, Patient Care
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5450
- Medical specialty
- General Hospital
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GO-CLEAN (K922110) | Viva-Tek Assoc., Inc. | 1994-03-09 |
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Every clearance here is in the API, with alerts when new ones post.