The following data is part of a premarket notification filed by Micromedical Devices, Inc. with the FDA for Trans-pace.
| Device ID | K834262 |
| 510k Number | K834262 |
| Device Name: | TRANS-PACE |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | MICROMEDICAL DEVICES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-08 |
| Decision Date | 1984-02-04 |