The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Misty Ox Turboheater.
| Device ID | K962438 |
| 510k Number | K962438 |
| Device Name: | MISTY OX TURBOHEATER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | VITAL SIGNS, INC. 1060 NORTH BATAVIA, UNIT H Orange, CA 92867 |
| Contact | Douglas R Mongeon |
| Correspondent | Douglas R Mongeon VITAL SIGNS, INC. 1060 NORTH BATAVIA, UNIT H Orange, CA 92867 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-24 |
| Decision Date | 1997-01-13 |