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FDA 510(k)

EASTGATE PERSONAL MONITOR

K-Number: K990731 · 1999-05-19

ApplicantEastgate Trading Corp.
Decision Date1999-05-19
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EASTGATE PERSONAL MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Eastgate Trading Corp.. It received FDA 510(k) clearance on 1999-05-19 under 510(k) number K990731. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASTGATE PERSONAL MONITOR?

EASTGATE PERSONAL MONITOR is a medical device that received FDA 510(k) clearance on 1999-05-19. The listed applicant is Eastgate Trading Corp.. The 510(k) number is K990731.

When did EASTGATE PERSONAL MONITOR receive FDA 510(k) clearance?

EASTGATE PERSONAL MONITOR received FDA 510(k) clearance on 1999-05-19, under 510(k) number K990731.

Who is the listed applicant for EASTGATE PERSONAL MONITOR?

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

What is the FDA product code for EASTGATE PERSONAL MONITOR?

The FDA product code for EASTGATE PERSONAL MONITOR is GCJ.

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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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