The following data is part of a premarket notification filed by Eaton Medical Group with the FDA for Model Tt-185 Telemetry Transmitter.
Device ID | K851624 |
510k Number | K851624 |
Device Name: | MODEL TT-185 TELEMETRY TRANSMITTER |
Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
Applicant | EATON MEDICAL GROUP P.O. BOX 276 Eaton, MI |
Contact | Paul P Kluwe |
Correspondent | Paul P Kluwe EATON MEDICAL GROUP P.O. BOX 276 Eaton, MI |
Product Code | DXH |
CFR Regulation Number | 870.2920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-18 |
Decision Date | 1986-01-14 |