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FDA 510(k)

ZOLL M SERIES ETC02 LOFLO OPTION

K-Number: K042417 · 2004-10-05

ApplicantZoll Medical Corp
Decision Date2004-10-05
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOLL M SERIES ETC02 LOFLO 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 2004-10-05 under 510(k) number K042417. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZOLL M SERIES ETC02 LOFLO OPTION?

ZOLL M SERIES ETC02 LOFLO OPTION is a medical device that received FDA 510(k) clearance on 2004-10-05. The listed applicant is Zoll Medical Corp. The 510(k) number is K042417.

When did ZOLL M SERIES ETC02 LOFLO OPTION receive FDA 510(k) clearance?

ZOLL M SERIES ETC02 LOFLO OPTION received FDA 510(k) clearance on 2004-10-05, under 510(k) number K042417.

Who is the listed applicant for ZOLL M SERIES ETC02 LOFLO 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 ETC02 LOFLO OPTION?

The FDA product code for ZOLL M SERIES ETC02 LOFLO OPTION is MKJ. This falls under the Dental category.

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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 AUTOCLAVABLEK033474ZOLL AED PLUSK032691ZOLL AUTOCLAVABLE INTERNAL HANDLES

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Related Devices (Code: MKJ)

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.

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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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