510(k) K823774
K823774 is an FDA 510(k) premarket notification submitted by Antares Technical Associates, Inc. for the device "WILSON EUSTACHIAN TUBAL, SONOGRAPH". The FDA issued a decision of Substantially Equivalent on January 17, 1983. The device falls under product code ETK (Tube, Toynbee Diagnostic), a Class I device regulated under 21 CFR 874.1925.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1983
- Date Received
- December 14, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Toynbee Diagnostic
- Device Class
- Class I
- Regulation Number
- 874.1925
- Review Panel
- EN
- Submission Type