510(k) K860558
K860558 is an FDA 510(k) premarket notification submitted by Sharn, Inc. for the device "ESOPHAGEAL STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on April 1, 1986. The device falls under product code BZW (Stethoscope, Esophageal), a Class I device regulated under 21 CFR 868.1910. Sharn, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 1986
- Date Received
- February 14, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stethoscope, Esophageal
- Device Class
- Class I
- Regulation Number
- 868.1910
- Review Panel
- AN
- Submission Type