TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors
FDA premarket approval P200005 · decided 2024-01-09
Approval details
- PMA number
- P200005
- Trade name
- TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Tz Medical, Inc.
- Date received
- 2020-02-03
- Decision date
- 2024-01-09
- Days to decision
- 1436 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Portland, OR
- Statement
- for the TZ Medical Adult Multi-Function Defibrillation Electrodes and Adaptors and TZ Medical Pediatric Multi-Function Defibrillation Electrodes and Adaptors
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Arc Adjustable Radial Cuff Compression Device (K252772) | Tz Medical, Inc. | 2026-05-22 |
| ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE (K173563) | Tz Medical, Inc. | 2018-01-10 |
| TZ SKULL PIN Adult (K163322) | Tz Medical, Inc. | 2017-02-23 |
| AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR (K102507) | Tz Medical, Inc. | 2011-06-13 |
| V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC (K062577) | Tz Medical, Inc. | 2006-12-15 |
| NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND (K040208) | Tz Medical, Inc. | 2004-05-11 |
| PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE (K021421) | Tz Medical, Inc. | 2003-04-18 |
| CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 (K001634) | Tz Medical, Inc. | 2000-12-21 |