510(k) K173663
K173663 is an FDA 510(k) premarket notification submitted by Imediplus, Inc. for the device "Electronic Stethoscope DS3011A". The FDA issued a decision of Substantially Equivalent on Aug 17, 2018. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Imediplus, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 17, 2018
- Date Received
- Nov 29, 2017
- Clearance Type
- Abbreviated
- 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)