The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Precision Medical Oxygen Regulator.
| Device ID | K901831 |
| 510k Number | K901831 |
| Device Name: | PRECISION MEDICAL OXYGEN REGULATOR |
| Classification | Regulator, Pressure, Gas Cylinder |
| Applicant | PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
| Contact | John R Selady |
| Correspondent | John R Selady PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
| Product Code | CAN |
| CFR Regulation Number | 868.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-24 |
| Decision Date | 1990-08-14 |