The following data is part of a premarket notification filed by Roche Medical Electronics, Inc. with the FDA for Monitor, Heart Rate Model 103.
| Device ID | K782089 |
| 510k Number | K782089 |
| Device Name: | MONITOR, HEART RATE MODEL 103 |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | ROCHE MEDICAL ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-14 |
| Decision Date | 1979-01-04 |