OXY-OFF(TM)— 510(k) K863510
Substantially EquivalentB&B Medical Technologies, Inc.
FDA 510(k) clearance K863510 for OXY-OFF(TM), Substantially Equivalent on 1986-10-22. Applicant: B&B Medical Technologies, Inc.. Device class: 1.
Clearance details
- Applicant
- B&B Medical Technologies, Inc.
- Product code
- Code BXY
- Device class
- Class 1
- Regulation
- 21 CFR 868.2350
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orangevale, CA, US
Recent devices under product code BXY
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