The following data is part of a premarket notification filed by Medical Fittings, Inc. with the FDA for Ohmeda Style Check Units (female Couplers).
| Device ID | K912763 |
| 510k Number | K912763 |
| Device Name: | OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS) |
| Classification | Tubing, Pressure And Accessories |
| Applicant | MEDICAL FITTINGS, INC. 300 HELD DR. Northampton, PA 18067 |
| Contact | John Selady |
| Correspondent | John 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 | 1991-06-24 |
| Decision Date | 1991-10-15 |