510(k) K982193
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 1998
- Date Received
- June 22, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stethoscope, Esophageal, With Electrical Conductors
- Device Class
- Class II
- Regulation Number
- 868.1920
- Review Panel
- AN
- Submission Type