510(k) K203007
K203007 is an FDA 510(k) premarket notification submitted by Chip Ideas Electronics S.L. for the device "eKuore Pro Series". The FDA issued a decision of Substantially Equivalent on Oct 30, 2020. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Chip Ideas Electronics S.L. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 30, 2020
- Date Received
- Oct 1, 2020
- 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)