510(k) K220766
K220766 is an FDA 510(k) premarket notification submitted by Csd Labs GmbH for the device "eMurmur Heart AI". The FDA issued a decision of Substantially Equivalent on May 31, 2022. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Csd Labs GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2022
- Date Received
- March 16, 2022
- Clearance Type
- Special
- 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