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FDA 510(k)

QUIK-PACE II ELECTRODES

K-Number: K883121 · 1988-09-20

Decision Date1988-09-20
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUIK-PACE II ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Physio-Control Corp.. It received FDA 510(k) clearance on 1988-09-20 under 510(k) number K883121. The device is classified under product code DRO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIK-PACE II ELECTRODES?

QUIK-PACE II ELECTRODES is a medical device that received FDA 510(k) clearance on 1988-09-20. The listed applicant is Physio-Control Corp.. The 510(k) number is K883121.

When did QUIK-PACE II ELECTRODES receive FDA 510(k) clearance?

QUIK-PACE II ELECTRODES received FDA 510(k) clearance on 1988-09-20, under 510(k) number K883121.

Who is the listed applicant for QUIK-PACE II ELECTRODES?

The FDA 510(k) record lists Physio-Control Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUIK-PACE II ELECTRODES?

The FDA product code for QUIK-PACE II ELECTRODES is DRO.

Related Clinical Trials

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.

Other records listing Physio-Control 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.

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Related Devices (Code: DRO)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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