510(k) K961060
K961060 is an FDA 510(k) premarket notification submitted by Aristo Medical Products, Inc. for the device "ARISTO ESOPHAGEAL STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on June 19, 1996. The device falls under product code BZT (Stethoscope, Esophageal, With Electrical Conductors), a Class II device regulated under 21 CFR 868.1920. Aristo Medical Products, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 1996
- Date Received
- March 18, 1996
- 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