FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POWERCHARGER
K Number: K934016
·
Decision Oct 18, 1994
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
64
Applicant Total
33
Review Days
426
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Basic Information
- Device Name
- POWERCHARGER
- K Number
- K934016
- 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
- August 18, 1993
- Decision Date
- October 18, 1994
- 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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Other Clearances by Zoll Medical Corp
| K Number | Device Name | ||
|---|---|---|---|
| K133484 | ZOLL X SERIES | Aug 1, 2014 | Substantially Equivalent |
| K112660 | POCKETCPR | May 10, 2012 | Substantially Equivalent |
| K090989 | ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES | Sep 23, 2009 | Substantially Equivalent |
| K042007 | ZOLL E SERIES DEFIBRILLATOR | Apr 7, 2005 | Substantially Equivalent |
| K042302 | ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE | Oct 26, 2004 | Substantially Equivalent |
| K042417 | ZOLL M SERIES ETC02 LOFLO OPTION | Oct 5, 2004 | Substantially Equivalent |
| K033474 | ZOLL AED PLUS | May 21, 2004 | Substantially Equivalent |
| K032691 | ZOLL AUTOCLAVABLE INTERNAL HANDLES | Nov 13, 2003 | Substantially Equivalent |
| 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 |