The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Cd Telemetry Systems.
Device ID | K891104 |
510k Number | K891104 |
Device Name: | CD TELEMETRY SYSTEMS |
Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Contact | Thomas Massopust |
Correspondent | Thomas Massopust MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Product Code | DRG |
CFR Regulation Number | 870.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-02 |
Decision Date | 1989-04-19 |