The following data is part of a premarket notification filed by Tenacore Holdings, Inc. with the FDA for Tenacore Oxygen Blender, Model Tb-2000.
| Device ID | K081335 |
| 510k Number | K081335 |
| Device Name: | TENACORE OXYGEN BLENDER, MODEL TB-2000 |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | TENACORE HOLDINGS, INC. 647 EAST YOUNG ST. Santa Ana, CA 92705 |
| Contact | Brand Caso |
| Correspondent | Brand Caso TENACORE HOLDINGS, INC. 647 EAST YOUNG ST. Santa Ana, CA 92705 |
| Product Code | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-12 |
| Decision Date | 2008-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861269000213 | K081335 | 000 |
| 00861269000206 | K081335 | 000 |