510(k) K170874
K170874 is an FDA 510(k) premarket notification submitted by Eko Devices, Inc. for the device "Eko Model E5 System (EME5), Eko DUO". The FDA issued a decision of Substantially Equivalent on May 19, 2017. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Eko Devices, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 2017
- Date Received
- March 24, 2017
- 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