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FDA 510(k)

POWERCHARGER

K-Number: K934016 · 1994-10-18

ApplicantZoll Medical Corp
Decision Date1994-10-18
Product CodeDTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POWERCHARGER 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 1994-10-18 under 510(k) number K934016. The device is classified under product code DTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWERCHARGER?

POWERCHARGER is a medical device that received FDA 510(k) clearance on 1994-10-18. The listed applicant is Zoll Medical Corp. The 510(k) number is K934016.

When did POWERCHARGER receive FDA 510(k) clearance?

POWERCHARGER received FDA 510(k) clearance on 1994-10-18, under 510(k) number K934016.

Who is the listed applicant for POWERCHARGER?

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 POWERCHARGER?

The FDA product code for POWERCHARGER is DTE.

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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: DTE)

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.

K241781Solo Pace ControlSolo Pace, Inc.K232721Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K201011Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K190825Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K182839Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K181973Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, 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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