The following data is part of a premarket notification filed by Nova Health Systems, Inc. with the FDA for Nova Air Floatation System.
Device ID | K780502 |
510k Number | K780502 |
Device Name: | NOVA AIR FLOATATION SYSTEM |
Classification | Mattress, Air Flotation, Alternating Pressure |
Applicant | NOVA HEALTH SYSTEMS, INC. MD |
Product Code | FNM |
CFR Regulation Number | 880.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-03-29 |
Decision Date | 1978-04-10 |