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FDA 510(k)

ZOLL M SERIES

K-Number: K010257 · 2001-02-28

ApplicantZoll Medical Corp
Decision Date2001-02-28
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOLL M SERIES 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 2001-02-28 under 510(k) number K010257. 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?

ZOLL M SERIES is a medical device that received FDA 510(k) clearance on 2001-02-28. The listed applicant is Zoll Medical Corp. The 510(k) number is K010257.

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

ZOLL M SERIES received FDA 510(k) clearance on 2001-02-28, under 510(k) number K010257.

Who is the listed applicant for ZOLL M SERIES?

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?

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

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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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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.

K131550HEART SYNCHeart Sync, Inc.K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical SystemsK131494HEART SYNCHeart Sync, Inc.K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORPhysio-Control, Inc.K123881HEARTSINE SAMARITAN PAD 350PHeartsine Technologies, Inc.K130153HEARSTART MRX WITH AIRWAY CONFIMRATION ASSISTPhilips Medical Systems

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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