The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Clinical Data System (cam) Module.
| Device ID | K801029 |
| 510k Number | K801029 |
| Device Name: | CLINICAL DATA SYSTEM (CAM) MODULE |
| Classification | Booth, Sun Tan |
| Applicant | ADAC LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LEJ |
| CFR Regulation Number | 878.4635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-01 |
| Decision Date | 1980-05-28 |