510(k) K024205
K024205 is an FDA 510(k) premarket notification submitted by Everest Biomedical Instruments Co. for the device "AUDIOSCREENER OAE+ABR". The FDA issued a decision of Substantially Equivalent on March 7, 2003. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Everest Biomedical Instruments Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 2003
- Date Received
- December 20, 2002
- 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