FRR — Chamber, Reverse Isolation, Patient Care Class II
FDA product code FRR covers "Chamber, Reverse Isolation, Patient Care", a Class II medical device regulated under 21 CFR 880.5450. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- FRR
- Device Class
- Class II
- Regulation Number
- 880.5450
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K922110 | viva-tek assoc | GO-CLEAN | March 9, 1994 |