510(k) K223166
K223166 is an FDA 510(k) premarket notification submitted by Medaica, Inc. for the device "Medaica M1 Telehealth Stethoscope". The FDA issued a decision of Substantially Equivalent on January 19, 2023. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 19, 2023
- Date Received
- October 7, 2022
- 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