Atlas FDA

ZOLL M SERIES

FDA 510(k) clearance K010257 · decided 2001-02-28

Clearance details

K-number
K010257
Device name
ZOLL M SERIES
Applicant
Zoll Medical Corp
Decision
Substantially Equivalent
Date received
2001-01-29
Decision date
2001-02-28
Days to decision
30 days
Clearance type
Special
Product code
MKJ
Device class
3
Regulation number
870.5310
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Burlington, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Zoll M Series Automated Defibrillator (AED) recall (Z-1472-04)Zoll Medical Corporation2004-09-17