The following data is part of a premarket notification filed by Medical Fittings, Inc. with the FDA for Oxygen Coupler, Air Coupler & Vacuum Coupler.
| Device ID | K901961 |
| 510k Number | K901961 |
| Device Name: | OXYGEN COUPLER, AIR COUPLER & VACUUM COUPLER |
| Classification | Tubing, Pressure And Accessories |
| Applicant | MEDICAL FITTINGS, INC. 300 HELD DR. Northampton, PA 18067 |
| Contact | John R Selady |
| Correspondent | John R Selady MEDICAL FITTINGS, INC. 300 HELD DR. Northampton, PA 18067 |
| Product Code | BYX |
| CFR Regulation Number | 868.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-01 |
| Decision Date | 1990-08-14 |