510(k) K220099
K220099 is an FDA 510(k) premarket notification submitted by Homediagnostic, LLC for the device "eClinic Stethopod". The FDA issued a decision of Substantially Equivalent on Oct 20, 2022. 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
- Oct 20, 2022
- Date Received
- Jan 12, 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
- 510(k)