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FDA 510(k)

PATIENT ISOLATION UNIT, MODEL G019-1000

K-Number: K080117 · 2009-01-30

ApplicantGentex Corporation
Decision Date2009-01-30
Product CodeLGM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PATIENT ISOLATION UNIT, MODEL G019-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Gentex Corporation. It received FDA 510(k) clearance on 2009-01-30 under 510(k) number K080117. The device is classified under product code LGM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATIENT ISOLATION UNIT, MODEL G019-1000?

PATIENT ISOLATION UNIT, MODEL G019-1000 is a medical device that received FDA 510(k) clearance on 2009-01-30. The listed applicant is Gentex Corporation. The 510(k) number is K080117.

When did PATIENT ISOLATION UNIT, MODEL G019-1000 receive FDA 510(k) clearance?

PATIENT ISOLATION UNIT, MODEL G019-1000 received FDA 510(k) clearance on 2009-01-30, under 510(k) number K080117.

Who is the listed applicant for PATIENT ISOLATION UNIT, MODEL G019-1000?

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

What is the FDA product code for PATIENT ISOLATION UNIT, MODEL G019-1000?

The FDA product code for PATIENT ISOLATION UNIT, MODEL G019-1000 is LGM.

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Other records listing Gentex Corporation as applicant

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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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