510(k) K092716
K092716 is an FDA 510(k) premarket notification submitted by Truer Medical, Inc. for the device "ESOPHAGEAL STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on September 17, 2009. The device falls under product code BZT (Stethoscope, Esophageal, With Electrical Conductors), a Class II device regulated under 21 CFR 868.1920. Truer Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2009
- Date Received
- September 3, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Stethoscope, Esophageal, With Electrical Conductors
- Device Class
- Class II
- Regulation Number
- 868.1920
- Review Panel
- AN
- Submission Type