The following data is part of a premarket notification filed by Roche Medical Electronics, Inc. with the FDA for Monitor, Heart Rate Model 105.
Device ID | K782088 |
510k Number | K782088 |
Device Name: | MONITOR, HEART RATE MODEL 105 |
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 |