The following data is part of a premarket notification filed by Tz Medical, Inc. with the FDA for Cardiosentry Event Monitor, Model 8470-01.
Device ID | K001634 |
510k Number | K001634 |
Device Name: | CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 |
Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
Applicant | TZ MEDICAL, INC. 15858 S.W. UPPER BOONES FERRY RD. Lake Oswego, OR 97035 |
Contact | Byron Zahler |
Correspondent | Byron Zahler TZ MEDICAL, INC. 15858 S.W. UPPER BOONES FERRY RD. Lake Oswego, OR 97035 |
Product Code | DXH |
CFR Regulation Number | 870.2920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-05-26 |
Decision Date | 2000-12-21 |