The following data is part of a premarket notification filed by Danninger Medical Technology, Inc. with the FDA for Basic Shoulder Cpm.
| Device ID | K931128 |
| 510k Number | K931128 |
| Device Name: | BASIC SHOULDER CPM |
| Classification | Exerciser, Powered |
| Applicant | DANNINGER MEDICAL TECHNOLOGY, INC. C/O BUCKMAN CO., INC. 1000 BURNETT AVENUE, SUITE 250 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf DANNINGER MEDICAL TECHNOLOGY, INC. C/O BUCKMAN CO., INC. 1000 BURNETT AVENUE, SUITE 250 Concord, CA 94520 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-05 |
| Decision Date | 1994-05-06 |