FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
K Number: K983196
·
Decision Sep 15, 1999
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
83
Applicant Total
15
Review Days
369
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Basic Information
- Device Name
- PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
- K Number
- K983196
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5550
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tz Medical, Inc.
- Date Received
- September 11, 1998
- Decision Date
- September 15, 1999
- Product Code
- DRO
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
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CARDIOSERV P
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Other Clearances by Tz Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252772 | Arc Adjustable Radial Cuff Compression Device | May 22, 2026 | Substantially Equivalent |
| K173563 | ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE | Jan 10, 2018 | Substantially Equivalent |
| K163322 | TZ SKULL PIN Adult | Feb 23, 2017 | Substantially Equivalent |
| K102507 | AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR | Jun 13, 2011 | Substantially Equivalent |
| K062577 | V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC | Dec 15, 2006 | Substantially Equivalent |
| K040208 | NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND | May 11, 2004 | Substantially Equivalent |
| K021421 | PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE | Apr 18, 2003 | Substantially Equivalent |
| K001634 | CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 | Dec 21, 2000 | Substantially Equivalent |
| K993205 | BOOKER BOX, MODEL PAD 5010 | Jul 20, 2000 | Substantially Equivalent |
| K983232 | PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT | Sep 15, 1999 | Substantially Equivalent |