The following data is part of a premarket notification filed by Tz Medical, Inc. with the FDA for Electrocardiograph Transmitter.
Device ID | K923930 |
510k Number | K923930 |
Device Name: | ELECTROCARDIOGRAPH TRANSMITTER |
Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
Applicant | TZ MEDICAL, INC. 18603 WILLAMETTE DR. West Linn, OR 97068 |
Contact | Byron G Zahler |
Correspondent | Byron G Zahler TZ MEDICAL, INC. 18603 WILLAMETTE DR. West Linn, OR 97068 |
Product Code | DXH |
CFR Regulation Number | 870.2920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-05 |
Decision Date | 1992-10-21 |