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FDA 510(k)

ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION

K-Number: K011865 · 2001-07-31

ApplicantZoll Medical Corp
Decision Date2001-07-31
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Zoll Medical Corp. It received FDA 510(k) clearance on 2001-07-31 under 510(k) number K011865. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION?

ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION is a medical device that received FDA 510(k) clearance on 2001-07-31. The listed applicant is Zoll Medical Corp. The 510(k) number is K011865.

When did ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION receive FDA 510(k) clearance?

ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION received FDA 510(k) clearance on 2001-07-31, under 510(k) number K011865.

Who is the listed applicant for ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION?

The FDA 510(k) record lists Zoll Medical Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION?

The FDA product code for ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION is DSK.

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Other records listing Zoll Medical Corp as applicant

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K112660POCKETCPRK090989ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIESK042007ZOLL E SERIES DEFIBRILLATORK042302ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLEK042417ZOLL M SERIES ETC02 LOFLO OPTIONK033474ZOLL AED PLUS

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Related Devices (Code: DSK)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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