The following data is part of a premarket notification filed by Tz Medical, Inc. with the FDA for Padtak Pace/defib/cardiovert Monitoring Electrode(s).
| Device ID | K983196 |
| 510k Number | K983196 |
| Device Name: | PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| 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 | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-11 |
| Decision Date | 1999-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811331018103 | K983196 | 000 |
| 00811331017823 | K983196 | 000 |
| 00811331017816 | K983196 | 000 |
| 00811331017809 | K983196 | 000 |
| 00811331017793 | K983196 | 000 |
| 00811331017786 | K983196 | 000 |
| 00811331017779 | K983196 | 000 |
| 00811331017700 | K983196 | 000 |
| 00811331017694 | K983196 | 000 |
| 00811331017656 | K983196 | 000 |
| 00811331017649 | K983196 | 000 |
| 00811331017830 | K983196 | 000 |
| 00811331017847 | K983196 | 000 |
| 00811331018066 | K983196 | 000 |
| 00811331018059 | K983196 | 000 |
| 00811331018028 | K983196 | 000 |
| 00811331017984 | K983196 | 000 |
| 00811331017977 | K983196 | 000 |
| 00811331017946 | K983196 | 000 |
| 00811331017922 | K983196 | 000 |
| 00811331017878 | K983196 | 000 |
| 00811331017861 | K983196 | 000 |
| 00811331017854 | K983196 | 000 |
| 00811331017632 | K983196 | 000 |