The following data is part of a premarket notification filed by Gsi Development Co. with the FDA for Microair Turn-q.
Device ID | K926456 |
510k Number | K926456 |
Device Name: | MICROAIR TURN-Q |
Classification | Bed, Flotation Therapy, Powered |
Applicant | GSI DEVELOPMENT CO. 2 COMMERCE DR. Carmel, NY 10512 |
Contact | Oliver H Bodine |
Correspondent | Oliver H Bodine GSI DEVELOPMENT CO. 2 COMMERCE DR. Carmel, NY 10512 |
Product Code | IOQ |
CFR Regulation Number | 890.5170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-24 |
Decision Date | 1993-03-24 |