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FDA 510(k)

CORELIFE

K-Number: K964230 · 1997-07-24

ApplicantCore Healthcare , Ltd.
Decision Date1997-07-24
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CORELIFE is the device name listed in this FDA 510(k) record. The listed applicant is Core Healthcare , Ltd.. It received FDA 510(k) clearance on 1997-07-24 under 510(k) number K964230. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORELIFE?

CORELIFE is a medical device that received FDA 510(k) clearance on 1997-07-24. The listed applicant is Core Healthcare , Ltd.. The 510(k) number is K964230.

When did CORELIFE receive FDA 510(k) clearance?

CORELIFE received FDA 510(k) clearance on 1997-07-24, under 510(k) number K964230.

Who is the listed applicant for CORELIFE?

The FDA 510(k) record lists Core Healthcare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORELIFE?

The FDA product code for CORELIFE is FMF.

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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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