The following data is part of a premarket notification filed by Dermanetics Corp. with the FDA for System 3000 Fluidized Air Bed.
Device ID | K890935 |
510k Number | K890935 |
Device Name: | SYSTEM 3000 FLUIDIZED AIR BED |
Classification | Bed, Flotation Therapy, Powered |
Applicant | DERMANETICS CORP. 741 W. 17TH ST. Long Beach, CA 90813 |
Contact | Postle |
Correspondent | Postle DERMANETICS CORP. 741 W. 17TH ST. Long Beach, CA 90813 |
Product Code | IOQ |
CFR Regulation Number | 890.5170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-24 |
Decision Date | 1989-03-15 |