FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT
K Number: K983232
·
Decision Sep 15, 1999
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
83
Applicant Total
12
Review Days
366
Basic Information
- Device Name
- PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT
- K Number
- K983232
- 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 14, 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 |
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| K982228 | FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25 | Jan 14, 1999 | Substantially Equivalent |
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| K964888 | HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II | Feb 28, 1997 | Substantially Equivalent |