The following data is part of a premarket notification filed by Tz Medical, Inc. with the FDA for Heart Aide Multple/heart Aide Plus/heart Aide Plus Ii.
| Device ID | K964888 |
| 510k Number | K964888 |
| Device Name: | HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | TZ MEDICAL, INC. 15858 S.W. UPPER BOONES FERRY RD. Lake Oswego, OR 97035 |
| Contact | D. Jadeen Hailey |
| Correspondent | D. Jadeen Hailey 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 | 1996-12-06 |
| Decision Date | 1997-02-28 |