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FDA 510(k)

ZOLL AUTOCLAVABLE INTERNAL HANDLES

K-Number: K963781 · 1997-05-20

ApplicantZoll Medical Corp
Decision Date1997-05-20
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

ZOLL AUTOCLAVABLE INTERNAL HANDLES 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 1997-05-20 under 510(k) number K963781. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the ZOLL AUTOCLAVABLE INTERNAL HANDLES?

ZOLL AUTOCLAVABLE INTERNAL HANDLES is a medical device that received FDA 510(k) clearance on 1997-05-20. The listed applicant is Zoll Medical Corp. The 510(k) number is K963781.

When did ZOLL AUTOCLAVABLE INTERNAL HANDLES receive FDA 510(k) clearance?

ZOLL AUTOCLAVABLE INTERNAL HANDLES received FDA 510(k) clearance on 1997-05-20, under 510(k) number K963781.

Who is the listed applicant for ZOLL AUTOCLAVABLE INTERNAL HANDLES?

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 AUTOCLAVABLE INTERNAL HANDLES?

The FDA product code for ZOLL AUTOCLAVABLE INTERNAL HANDLES is LDD.

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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: LDD)

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.

K203231Switched Internal PaddlesPhilips North America, LLCK200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips CompanyK182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc.K103651CARDIOMEDCardio Medical Products, Inc.K103783EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRICFiab SpaK103334CARDIO MEDCardio Medical Products, Inc.

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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