BREATHING ZONE— 510(k) K831067
Substantially EquivalentUpper Four, Inc.
FDA 510(k) clearance K831067 for BREATHING ZONE, Substantially Equivalent on 1983-06-16. Applicant: Upper Four, Inc.. Device class: 2.
Clearance details
- Applicant
- Upper Four, Inc.
- Product code
- Code FRF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5045
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Terre Haute, IN, US
Recent devices under product code FRF
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