The following data is part of a premarket notification filed by Med General with the FDA for Cardiometer.
Device ID | K780117 |
510k Number | K780117 |
Device Name: | CARDIOMETER |
Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
Applicant | MED GENERAL 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 | 1978-01-23 |
Decision Date | 1978-02-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CARDIOMETER 78023167 not registered Dead/Abandoned |
Osypka Medical, Inc. 2000-08-27 |