The following data is part of a premarket notification filed by Nova Health Systems, Inc. with the FDA for Nova Oxygen Tent.
| Device ID | K893713 |
| 510k Number | K893713 |
| Device Name: | NOVA OXYGEN TENT |
| Classification | Tent, Oxygen |
| Applicant | NOVA HEALTH SYSTEMS, INC. 1001 LOWER LANDING RD. SUITE 409 Blackwood, NJ 08012 |
| Contact | Robert Delano |
| Correspondent | Robert Delano NOVA HEALTH SYSTEMS, INC. 1001 LOWER LANDING RD. SUITE 409 Blackwood, NJ 08012 |
| Product Code | BYL |
| CFR Regulation Number | 868.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-18 |
| Decision Date | 1989-08-21 |