510(k) K181612
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2018
- Date Received
- June 19, 2018
- 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