The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Artromot Multi Directional Ankle Cpm.
Device ID | K924484 |
510k Number | K924484 |
Device Name: | ARTROMOT MULTI DIRECTIONAL ANKLE CPM |
Classification | Exerciser, Powered |
Applicant | BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
Contact | David W Schlerf |
Correspondent | David W Schlerf BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
Product Code | BXB |
CFR Regulation Number | 890.5380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-03 |
Decision Date | 1993-03-22 |