510(k) K183710
K183710 is an FDA 510(k) premarket notification submitted by Avicena, LLC for the device "Vivio System". The FDA issued a decision of Substantially Equivalent on Oct 4, 2019. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Avicena, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 4, 2019
- Date Received
- Dec 31, 2018
- 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