The following data is part of a premarket notification filed by Mada Medical Products, Inc. with the FDA for Oxygen Regulator.
| Device ID | K950777 |
| 510k Number | K950777 |
| Device Name: | OXYGEN REGULATOR |
| Classification | Regulator, Pressure, Gas Cylinder |
| Applicant | MADA MEDICAL PRODUCTS, INC. 60 COMMERCE RD. Carlstadt, NJ 07072 |
| Contact | Jeffrey Adam |
| Correspondent | Jeffrey Adam MADA MEDICAL PRODUCTS, INC. 60 COMMERCE RD. Carlstadt, NJ 07072 |
| Product Code | CAN |
| CFR Regulation Number | 868.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-21 |
| Decision Date | 1995-04-14 |