Product code FRR— General Hospital
GO-CLEAN
- Classification name
- Chamber, Reverse Isolation, Patient Care
- Device class
- Class 2
- Regulation
- 21 CFR 880.5450
- Advisory panel
- General Hospital
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code FRR
FDA has cleared device under product code FRR, all in 1994, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code FRR
Recent clearances under product code FRR
Data sourced from openFDA. This site is unofficial and independent of the FDA.