The following data is part of a premarket notification filed by Sutter Biomedical, Inc. with the FDA for Sutter Cpm 2000.
| Device ID | K830649 |
| 510k Number | K830649 |
| Device Name: | SUTTER CPM 2000 |
| Classification | Exerciser, Powered |
| Applicant | SUTTER BIOMEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-01 |
| Decision Date | 1983-03-17 |