510(k) K081335
K081335 is an FDA 510(k) premarket notification submitted by Tenacore Holdings, Inc. for the device "TENACORE OXYGEN BLENDER, MODEL TB-2000". The FDA issued a decision of Substantially Equivalent on November 14, 2008. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330. Tenacore Holdings, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 14, 2008
- Date Received
- May 12, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mixer, Breathing Gases, Anesthesia Inhalation
- Device Class
- Class II
- Regulation Number
- 868.5330
- Review Panel
- AN
- Submission Type