The following data is part of a premarket notification filed by Micromedical Devices, Inc. with the FDA for Mdi 2000 - Pulse Generator.
| Device ID | K850791 |
| 510k Number | K850791 |
| Device Name: | MDI 2000 - PULSE GENERATOR |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | MICROMEDICAL DEVICES, INC. 12741 EAST CALEY AVE. SUITE 128 Englewood, CO 80111 |
| Contact | Karen Murphy |
| Correspondent | Karen Murphy MICROMEDICAL DEVICES, INC. 12741 EAST CALEY AVE. SUITE 128 Englewood, CO 80111 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-26 |
| Decision Date | 1985-06-19 |