The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Telemetry Sys Series 7700 Ecg.
Device ID | K832817 |
510k Number | K832817 |
Device Name: | TELEMETRY SYS SERIES 7700 ECG |
Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
Applicant | MARQUETTE ELECTRONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DRG |
CFR Regulation Number | 870.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-19 |
Decision Date | 1984-01-10 |