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FDA 510(k)

DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION

K-Number: K921207 · 1992-10-13

ApplicantPhysiometrix, Inc.
Decision Date1992-10-13
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION is the device name listed in this FDA 510(k) record. The listed applicant is Physiometrix, Inc.. It received FDA 510(k) clearance on 1992-10-13 under 510(k) number K921207. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION?

DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION is a medical device that received FDA 510(k) clearance on 1992-10-13. The listed applicant is Physiometrix, Inc.. The 510(k) number is K921207.

When did DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION receive FDA 510(k) clearance?

DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION received FDA 510(k) clearance on 1992-10-13, under 510(k) number K921207.

Who is the listed applicant for DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION?

The FDA 510(k) record lists Physiometrix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION?

The FDA product code for DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION is DRX.

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Related Devices (Code: DRX)

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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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