FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004
K Number: K960676
·
Decision Jun 5, 1996
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
64
Applicant Total
33
Review Days
106
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Basic Information
- Device Name
- ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004
- K Number
- K960676
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3600
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Zoll Medical Corp
- Date Received
- February 20, 1996
- Decision Date
- June 5, 1996
- Product Code
- DTE
- 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 |
|---|---|---|---|
| DTE | Pulse-Generator, Pacemaker, External | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K032439 | ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) | Nov 5, 2003 | Substantially Equivalent |
| K032363 | ZOLL M SERIES NIBP OPTION | Oct 31, 2003 | Substantially Equivalent |