THINKLABS MEDICAL, LLC

Address:6500 S Quebec St Ste 210,Englewood,CO,80111,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stethoscope, Electronic (DQD) (1)

Premarket Exempt

Clear

Thinklabs - 00899529001106 Catalog Number :

Device Description : The Thinklabs One Digital Stethoscope is intended for use as a diagnostic aid in The Thinklabs One Digital Stethoscope is intended for use as a diagnostic aid in patient diagnosis. It can be used for the amplification of heart, lung, and other body sounds with selective frequency filtering. This product is not designed, sold, or intended for any use except as indicated.The Thinklabs One is designed to be used by medical and allied professionals and trainees enrolled in professional training programs. Operation of the device requires no special training beyond the user following the instructions for use on Thinklabs website. Accurate patient diagnosis with a stethoscope requires the operator to have auscultation skills.

Device Class : 2

Duns Number: 011804706

Premarket Exempt : No

Product Code : DQD

Prescription Use : Yes

Device Count : 1

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