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 |