510(k) K233609
K233609 is an FDA 510(k) premarket notification submitted by Eko Health, Inc. for the device "CORE 500 Digital Stethoscope". The FDA issued a decision of Substantially Equivalent on March 28, 2024. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Eko Health, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2024
- Date Received
- November 13, 2023
- 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