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FDA 510(k)

ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR

K-Number: K942344 · 1995-03-13

ApplicantZoll Medical Corp
Decision Date1995-03-13
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR 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 1995-03-13 under 510(k) number K942344. 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 PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR?

ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR is a medical device that received FDA 510(k) clearance on 1995-03-13. The listed applicant is Zoll Medical Corp. The 510(k) number is K942344.

When did ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR receive FDA 510(k) clearance?

ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR received FDA 510(k) clearance on 1995-03-13, under 510(k) number K942344.

Who is the listed applicant for ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR?

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 PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR?

The FDA product code for ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR 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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