Chamber, Reverse Isolation, Patient Care
A patient care reverse isolation chamber is a protective enclosure used to shield immunocompromised patients from environmental contaminants and infectious agents, providing a controlled clean-air environment. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FRR, regulated under 21 CFR 880.5450, within the General Hospital medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- FRR
- Device Class
- FDA class 2
- Regulation Number
- 880.5450
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K922110 | GO-CLEAN | Mar 09, 1994 | Substantially Equivalent | Viva-Tek Assoc., Inc. |