The following data is part of a premarket notification filed by Baltimore Therapeutic Equipment Co. with the FDA for Bte Cpm-10.
| Device ID | K955105 |
| 510k Number | K955105 |
| Device Name: | BTE CPM-10 |
| Classification | Exerciser, Powered |
| Applicant | BALTIMORE THERAPEUTIC EQUIPMENT CO. 7455-L NEW RIDGE RD. Hanover, MD 21076 |
| Contact | Christine Delaney |
| Correspondent | Christine Delaney BALTIMORE THERAPEUTIC EQUIPMENT CO. 7455-L NEW RIDGE RD. Hanover, MD 21076 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-08 |
| Decision Date | 1995-12-29 |