FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
K Number: K102507
·
Decision Jun 13, 2011
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
15
Review Days
285
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Basic Information
- Device Name
- AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
- K Number
- K102507
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tz Medical, Inc.
- Date Received
- September 1, 2010
- Decision Date
- June 13, 2011
- Product Code
- DSI
- 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | FDA class 2 | Cardiovascular |
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| 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 |
| K983196 | PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) | Sep 15, 1999 | Substantially Equivalent |