The following data is part of a premarket notification filed by Air-shields Vickers, Inc. with the FDA for Oxycare(tm) Oxygen Controller/monitor.
| Device ID | K924679 |
| 510k Number | K924679 |
| Device Name: | OXYCARE(TM) OXYGEN CONTROLLER/MONITOR |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Applicant | AIR-SHIELDS VICKERS, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Contact | Francis X Casey |
| Correspondent | Francis X Casey AIR-SHIELDS VICKERS, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Product Code | KLK |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-16 |
| Decision Date | 1995-02-21 |