The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Artromot(tm) Cpm Devices.
| Device ID | K895015 |
| 510k Number | K895015 |
| Device Name: | ARTROMOT(TM) CPM DEVICES |
| Classification | Exerciser, Powered |
| Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-08 |
| Decision Date | 1989-09-11 |