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FDA 510(k)

HARIKY, MODEL GK-7

K-Number: K860772 · 1986-05-09

ApplicantK-Mot, Inc.
Decision Date1986-05-09
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HARIKY, MODEL GK-7 is the device name listed in this FDA 510(k) record. The listed applicant is K-Mot, Inc.. It received FDA 510(k) clearance on 1986-05-09 under 510(k) number K860772. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARIKY, MODEL GK-7?

HARIKY, MODEL GK-7 is a medical device that received FDA 510(k) clearance on 1986-05-09. The listed applicant is K-Mot, Inc.. The 510(k) number is K860772.

When did HARIKY, MODEL GK-7 receive FDA 510(k) clearance?

HARIKY, MODEL GK-7 received FDA 510(k) clearance on 1986-05-09, under 510(k) number K860772.

Who is the listed applicant for HARIKY, MODEL GK-7?

The FDA 510(k) record lists K-Mot, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HARIKY, MODEL GK-7?

The FDA product code for HARIKY, MODEL GK-7 is GZJ.

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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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