The following data is part of a premarket notification filed by Litton Medical Electronics with the FDA for Recomb Ecg Preamplifier/206 069 03.
| Device ID | K834600 |
| 510k Number | K834600 |
| Device Name: | RECOMB ECG PREAMPLIFIER/206 069 03 |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | LITTON MEDICAL ELECTRONICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-30 |
| Decision Date | 1984-06-01 |