The following data is part of a premarket notification filed by Tz Medical, Inc. with the FDA for Fm Demodulator-4 Lead Model #8500-05 And Fm Demodulator-12 Lead Model # 8500-25.
| Device ID | K982228 |
| 510k Number | K982228 |
| Device Name: | FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25 |
| 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 | 1998-06-25 |
| Decision Date | 1999-01-14 |