510(k) K160401
K160401 is an FDA 510(k) premarket notification submitted by Tyto Care , Ltd. for the device "Tyto Stethoscope". The FDA issued a decision of Substantially Equivalent on October 19, 2016. 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
- October 19, 2016
- Date Received
- February 12, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stethoscope, Electronic
- Device Class
- Class II
- Regulation Number
- 870.1875
- Review Panel
- CV
- Submission Type