The following data is part of a premarket notification filed by Gsi Development Co. with the FDA for Microair Fluidized Air Bed.
Device ID | K884529 |
510k Number | K884529 |
Device Name: | MICROAIR FLUIDIZED AIR BED |
Classification | Bed, Air Fluidized |
Applicant | GSI DEVELOPMENT CO. 2 COMMERCE DR. Carmel, NY 10512 |
Contact | Bodine, Jr |
Correspondent | Bodine, Jr GSI DEVELOPMENT CO. 2 COMMERCE DR. Carmel, NY 10512 |
Product Code | INX |
CFR Regulation Number | 890.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-28 |
Decision Date | 1988-11-18 |