The following data is part of a premarket notification filed by Trans Pace, Inc. with the FDA for Transthoracic Temp. Pacemaker #100tpe.
| Device ID | K820232 |
| 510k Number | K820232 |
| Device Name: | TRANSTHORACIC TEMP. PACEMAKER #100TPE |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | TRANS PACE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-28 |
| Decision Date | 1982-04-09 |