Duns Number:649125325
Device Description: The Tyto Stethoscope is an electronic stethoscope that enables transmission ofauscultation The Tyto Stethoscope is an electronic stethoscope that enables transmission ofauscultation sound data, whereby a clinician at one location on an IP network can listen tothe auscultation sounds of a patient on site or at a different location on the IP network withthe signal carried on an IP connection between the two locations. The Tyto stethoscopeis intended for use by professional users in a clinical environment or in conjunction withpatients or lay users in a non-clinical environment.
Catalog Number
800-00001
Brand Name
Tyto Stethoscope
Version/Model Number
Tyto Stethoscope
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DQD
Product Code Name
Stethoscope, Electronic
Public Device Record Key
b634a263-1353-4adb-8a50-edbff5b7926e
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
December 22, 2016
Package DI Number
17290016672012
Quantity per Package
1
Contains DI Package
07290016672015
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |