The following data is part of a premarket notification filed by Therapy Air Support Systems, Inc. with the FDA for Tassi Mk3 (turnair).
Device ID | K910851 |
510k Number | K910851 |
Device Name: | TASSI MK3 (TURNAIR) |
Classification | Bed, Flotation Therapy, Powered |
Applicant | THERAPY AIR SUPPORT SYSTEMS, INC. 13912 PONDEROSA, UNIT-H Santa Ana, CA 92705 |
Contact | Bill Ross |
Correspondent | Bill Ross THERAPY AIR SUPPORT SYSTEMS, INC. 13912 PONDEROSA, UNIT-H Santa Ana, CA 92705 |
Product Code | IOQ |
CFR Regulation Number | 890.5170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-28 |
Decision Date | 1991-05-15 |