FDA 510(k) Application Details - K024205

Device Classification Name Audiometer

  More FDA Info for this Device
510(K) Number K024205
Device Name Audiometer
Applicant EVEREST BIOMEDICAL INSTRUMENTS CO.
16690 SWINGLEY RIDGE RD.
SUITE 140
CHESTERFIELD, MO 63017 US
Other 510(k) Applications for this Company
Contact RANDALL KROHN
Other 510(k) Applications for this Contact
Regulation Number 874.1050

  More FDA Info for this Regulation Number
Classification Product Code EWO
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 12/20/2002
Decision Date 03/07/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact