510(k) K212906
K212906 is an FDA 510(k) premarket notification submitted by Heartbuds, LLC for the device "HeartBuds Electronic Stethoscope". The FDA issued a decision of Substantially Equivalent on Mar 14, 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
- Mar 14, 2023
- Date Received
- Sep 13, 2021
- 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
- 510(k)