The following data is part of a premarket notification filed by Sutter Corp. with the FDA for Sutter Hospital Cpm.
| Device ID | K890607 |
| 510k Number | K890607 |
| Device Name: | SUTTER HOSPITAL CPM |
| Classification | Exerciser, Powered |
| Applicant | SUTTER CORP. 9425 CHESAPEAKE DR. San Diego, CA 92123 |
| Contact | H Mizoguchi |
| Correspondent | H Mizoguchi SUTTER CORP. 9425 CHESAPEAKE DR. San Diego, CA 92123 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-06 |
| Decision Date | 1989-02-27 |