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FDA 510(k)

ADR-10600(ADR 400),10601 (ADR 300)

K-Number: K791342 · 1979-11-16

ApplicantPhysio-Control Corp.
Decision Date1979-11-16
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ADR-10600(ADR 400),10601 (ADR 300) 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 1979-11-16 under 510(k) number K791342. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADR-10600(ADR 400),10601 (ADR 300)?

ADR-10600(ADR 400),10601 (ADR 300) is a medical device that received FDA 510(k) clearance on 1979-11-16. The listed applicant is Physio-Control Corp.. The 510(k) number is K791342.

When did ADR-10600(ADR 400),10601 (ADR 300) receive FDA 510(k) clearance?

ADR-10600(ADR 400),10601 (ADR 300) received FDA 510(k) clearance on 1979-11-16, under 510(k) number K791342.

Who is the listed applicant for ADR-10600(ADR 400),10601 (ADR 300)?

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 ADR-10600(ADR 400),10601 (ADR 300)?

The FDA product code for ADR-10600(ADR 400),10601 (ADR 300) is FKX.

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.

K991910LIFEPAK 12 BIPHASICK990338NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEMK983393LIFEPAK 500 BIPHASICK973486LIFE PAK 12K962359LIFEPAK 300K955854LIFEPAK 500

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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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