510(k) K962995
K962995 is an FDA 510(k) premarket notification submitted by Otodynamics, Ltd. for the device "ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC". The FDA issued a decision of Substantially Equivalent on January 10, 1997. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Otodynamics, Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 1997
- Date Received
- August 1, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Audiometer
- Device Class
- Class II
- Regulation Number
- 874.1050
- Review Panel
- EN
- Submission Type