The following data is part of a premarket notification filed by Bio Clinic Co. with the FDA for Orthoderm Convertible Ii.
Device ID | K922140 |
510k Number | K922140 |
Device Name: | ORTHODERM CONVERTIBLE II |
Classification | Bed, Flotation Therapy, Powered |
Applicant | BIO CLINIC CO. 4083 E. AIRPORT DR. Ontario, CA 91761 |
Contact | Greg Godfrey |
Correspondent | Greg Godfrey BIO CLINIC CO. 4083 E. AIRPORT DR. Ontario, CA 91761 |
Product Code | IOQ |
CFR Regulation Number | 890.5170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-06 |
Decision Date | 1992-05-27 |