FDA 510(k)

InTouch Thermal Camera

Numéro K : K181716 · 2019-03-25

DemandeurIntouch Technologies, Inc., D.B.A. Intouch Health

Date de décision2019-03-25

Code produitLHQ

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

InTouch Thermal Camera is the device name listed in this FDA 510(k) record. The listed applicant is Intouch Technologies, Inc., D.B.A. Intouch Health. It received FDA 510(k) clearance on 2019-03-25 under 510(k) number K181716. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the InTouch Thermal Camera?

InTouch Thermal Camera is a medical device that received FDA 510(k) clearance on 2019-03-25. The listed applicant is Intouch Technologies, Inc., D.B.A. Intouch Health. The 510(k) number is K181716.

When did InTouch Thermal Camera receive FDA 510(k) clearance?

InTouch Thermal Camera received FDA 510(k) clearance on 2019-03-25, under 510(k) number K181716.

Who is the listed applicant for InTouch Thermal Camera?

The FDA 510(k) record lists Intouch Technologies, Inc., D.B.A. Intouch Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InTouch Thermal Camera?

The FDA product code for InTouch Thermal Camera is LHQ.

Essais cliniques associés

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Dispositifs connexes (Code : LHQ)

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Source officielle

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