The following data is part of a premarket notification filed by Sutter Biomedical, Inc. with the FDA for Sutter Cpm.
| Device ID | K820083 |
| 510k Number | K820083 |
| Device Name: | SUTTER CPM |
| Classification | Exerciser, Powered |
| Applicant | SUTTER BIOMEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-12 |
| Decision Date | 1982-01-28 |