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 |