510(k) K964426
K964426 is an FDA 510(k) premarket notification submitted by Intelligent Hearing Systems for the device "SMARTOAE". The FDA issued a decision of Substantially Equivalent on February 3, 1997. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Intelligent Hearing Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 1997
- Date Received
- November 5, 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