TENACORE OXYGEN BLENDER, MODEL TB-2000— 510(k) K081335
Substantially EquivalentTenacore Holdings, Inc.
FDA 510(k) clearance K081335 for TENACORE OXYGEN BLENDER, MODEL TB-2000, Substantially Equivalent on 2008-11-14. Applicant: Tenacore Holdings, Inc.. Device class: 2.
Clearance details
- Applicant
- Tenacore Holdings, Inc.
- Product code
- Code BZR
- Device class
- Class 2
- Regulation
- 21 CFR 868.5330
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
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