510(k) K151319
K151319 is an FDA 510(k) premarket notification submitted by Eko Devices, Inc. for the device "Eko Electronic Stethoscope System". The FDA issued a decision of Substantially Equivalent on Aug 28, 2015. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Eko Devices, Inc. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 28, 2015
- Date Received
- May 18, 2015
- 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
- 510(k)