FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES
K Number: K090989
·
Decision Sep 23, 2009
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
227
Applicant Total
33
Review Days
169
Basic Information
- Device Name
- ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES
- K Number
- K090989
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ZOLL MEDICAL CORP.
- Date Received
- April 7, 2009
- Decision Date
- September 23, 2009
- Product Code
- MKJ
- 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 |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | FDA class 3 | 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 |
| 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 |
| K011541 | ZOLL PAD WITH CPR AID | Apr 11, 2002 | Substantially Equivalent - Subject to Tracking Reg. |