FDA.reportPublic FDA data

THINKLABS MEDICAL LLC

Matched from indexed company URL: THINKLABS INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30042152653004215265THINKLABS MEDICAL LLC1N2026-01-016500 S Quebec St Ste 210 Englewood CO US 80111

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00899529001106Thinklabs - 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.1 800 918 1088support@thinklabs.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
219391842963013K032230RHYTHM DIGITAL ELECTRONIC STETHOSCOPEDQD2003-11-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQD22003-11-26

PMN#

GUDID#

Thinklabs - 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.

THINKLABS MEDICAL, LLC

2016-09-19