The following data is part of a premarket notification filed by Fvtnks with the FDA for Disposable, Cpap Oxygen Mask.
| Device ID | K945482 |
| 510k Number | K945482 |
| Device Name: | DISPOSABLE, CPAP OXYGEN MASK |
| Classification | Mask, Oxygen |
| Applicant | FVTNKS 67920 KLINGER LAKE RD. Sturgis, MI 49091 -9288 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden FVTNKS 67920 KLINGER LAKE RD. Sturgis, MI 49091 -9288 |
| Product Code | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-08 |
| Decision Date | 1995-09-19 |