510(k) K970555
K970555 is an FDA 510(k) premarket notification submitted by Smith for the device "IL0292 DP ECHOPORT". The FDA issued a decision of Substantially Equivalent on March 17, 1997. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Smith has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1997
- Date Received
- February 13, 1997
- 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