510(k) K963681
K963681 is an FDA 510(k) premarket notification submitted by Benson Medical Instruments Co. for the device "CCA-100 (MODIFIED)". The FDA issued a decision of Substantially Equivalent on October 8, 1996. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Benson Medical Instruments Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 1996
- Date Received
- July 11, 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