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Drigel Defibrillator/Synchronized Coardioversion

by Physiometrix, Inc.

510(k) K921207

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK921207 Date13 Oct 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DRX
Device Class
Class II
Regulation
21 CFR Part 870.2360
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Drigel Defibrillator/Synchronized Cardioversion is an electrocardiograph electrode used for cardiac monitoring and therapy. It is designed to facilitate defibrillation and synchronized cardioversion procedures.

This device is identified by FDA 510(k) number K921207 and is classified as a Class 2 medical device. It is manufactured by Physiometrix, Inc. and received FDA 510(k) clearance on October 13, 1992.

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Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Drigel electrode?

    The Drigel Defibrillator/Synchronized Cardioversion electrode is designed to facilitate cardiac monitoring and therapy, specifically supporting defibrillation and synchronized cardioversion procedures.

  • What is the regulatory status of this device?

    The Drigel Defibrillator/Synchronized Cardioversion received FDA 510(k) clearance on October 13, 1992, under the submission number K921207. It is classified as a Class 2 medical device.

  • Who is the manufacturer of the Drigel electrode?

    This device is manufactured by Physiometrix, Inc., located in Sunnyvale, California. The company submitted the device for FDA 510(k) clearance, which was granted under the product code DRX.