510(k) K181612
K181612 is an FDA 510(k) premarket notification submitted by Tyto Care , Ltd. for the device "Tyto Stethoscope (OTC)". The FDA issued a decision of Substantially Equivalent on December 17, 2018. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Tyto Care , Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2018
- Date Received
- June 19, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Stethoscope, Electronic
- Device Class
- Class II
- Regulation Number
- 870.1875
- Review Panel
- CV
- Submission Type