The following data is part of a premarket notification filed by Tz Medical, Inc. with the FDA for Padtak Pediatric Defib/cardiovert/pace/monitor-radiotransparent (2x2.25),model 2602, Padtak Pediatric Defib/cardiovert.
| Device ID | K983232 |
| 510k Number | K983232 |
| Device Name: | PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | TZ MEDICAL, INC. 15858 S.W. UPPER BOONES FERRY RD. Lake Oswego, OR 97035 |
| Contact | Byron G Zahler |
| Correspondent | Byron G 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 | 1998-09-14 |
| Decision Date | 1999-09-15 |