510(k) K854125
K854125 is an FDA 510(k) premarket notification submitted by Craigwell Electronics, Ltd. for the device "CRAIGWELL AID FITTING SYSTEM AFS". The FDA issued a decision of Substantially Equivalent on January 16, 1986. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Craigwell Electronics, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 1986
- Date Received
- October 9, 1985
- 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