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FDA 510(k)

QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES

K-Number: K970391 · 1997-03-06

ApplicantContour Medical Technology, Inc.
Decision Date1997-03-06
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES 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 1997-03-06 under 510(k) number K970391. 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 QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES?

QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES is a medical device that received FDA 510(k) clearance on 1997-03-06. The listed applicant is Contour Medical Technology, Inc.. The 510(k) number is K970391.

When did QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES receive FDA 510(k) clearance?

QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES received FDA 510(k) clearance on 1997-03-06, under 510(k) number K970391.

Who is the listed applicant for QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES?

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 QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES?

The FDA product code for QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES 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.

K970125NOAH MONITORING ELECTRODE SYSTEMK960329DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PADK952805TEMPERATURE PROBE-TP550K952800TEMPERATURE PROBE-TP150K952804TEMPERATURE PROBE-TP450K952807TEMPERATURE PROBE-TP650

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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.

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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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