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FDA 510(k)

ZOLL M SERIES NIBP OPTION

K-Number: K032363 · 2003-10-31

ApplicantZoll Medical Corp
Decision Date2003-10-31
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOLL M SERIES NIBP 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 2003-10-31 under 510(k) number K032363. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZOLL M SERIES NIBP OPTION?

ZOLL M SERIES NIBP OPTION is a medical device that received FDA 510(k) clearance on 2003-10-31. The listed applicant is Zoll Medical Corp. The 510(k) number is K032363.

When did ZOLL M SERIES NIBP OPTION receive FDA 510(k) clearance?

ZOLL M SERIES NIBP OPTION received FDA 510(k) clearance on 2003-10-31, under 510(k) number K032363.

Who is the listed applicant for ZOLL M SERIES NIBP 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 NIBP OPTION?

The FDA product code for ZOLL M SERIES NIBP OPTION is DXN.

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Other records listing Zoll Medical Corp as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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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