Duns Number:011804706
Device Description: The Thinklabs One Digital Stethoscope is intended for use as a diagnostic aid in patient d 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.
Catalog Number
-
Brand Name
Thinklabs
Version/Model Number
One
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2050
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K032230
Product Code
DQD
Product Code Name
Stethoscope, Electronic
Public Device Record Key
22da8d0c-8c99-489b-bb9d-a9d3a762e148
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 19, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |