The following data is part of a premarket notification filed by B & B Medical Technologies, Inc. with the FDA for Oxy-off(tm).
| Device ID | K863510 |
| 510k Number | K863510 |
| Device Name: | OXY-OFF(TM) |
| Classification | Flowmeter, Calibration, Gas |
| Applicant | B & B MEDICAL TECHNOLOGIES, INC. P.O. BOX 1503 Orangevale, CA 95662 |
| Contact | Briggs, Iii |
| Correspondent | Briggs, Iii B & B MEDICAL TECHNOLOGIES, INC. P.O. BOX 1503 Orangevale, CA 95662 |
| Product Code | BXY |
| CFR Regulation Number | 868.2350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-09 |
| Decision Date | 1986-10-22 |