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FDA 510(k)

DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD

K-Number: K960329 · 1996-07-02

ApplicantContour Medical Technology, Inc.
Decision Date1996-07-02
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD is the device name listed in this FDA 510(k) record. The listed applicant is Contour Medical Technology, Inc.. It received FDA 510(k) clearance on 1996-07-02 under 510(k) number K960329. 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 DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD?

DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD is a medical device that received FDA 510(k) clearance on 1996-07-02. The listed applicant is Contour Medical Technology, Inc.. The 510(k) number is K960329.

When did DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD receive FDA 510(k) clearance?

DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD received FDA 510(k) clearance on 1996-07-02, under 510(k) number K960329.

Who is the listed applicant for DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD?

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

What is the FDA product code for DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD?

The FDA product code for DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD is MKJ. This falls under the Dental category.

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Other records listing Contour Medical Technology, Inc. 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.

K970391QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODESK970125NOAH MONITORING ELECTRODE SYSTEMK952800TEMPERATURE PROBE-TP150K952804TEMPERATURE PROBE-TP450K952803TEMPERATURE PROBE-TP350K952801TEMPERATURE PROBE-TP250

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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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