The following data is part of a premarket notification filed by Coherent Systems, Inc. with the FDA for E-fax Remote Monitor.
Device ID | K932863 |
510k Number | K932863 |
Device Name: | E-FAX REMOTE MONITOR |
Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
Applicant | COHERENT SYSTEMS, INC. 17000 EL CAMINO REAL SUITE 103 Houston, TX 77058 |
Contact | Tommy Cooper |
Correspondent | Tommy Cooper COHERENT SYSTEMS, INC. 17000 EL CAMINO REAL SUITE 103 Houston, TX 77058 |
Product Code | DXH |
CFR Regulation Number | 870.2920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-11 |
Decision Date | 1994-03-16 |