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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Otoscope
510(k) Number K932259
Device Name CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE
Applicant
Clarus Medical Systems, Inc.
2605 Fernbrook La
Minneapolis,  MN  55447
Applicant Contact GREGORY J MATHISON
Correspondent
Clarus Medical Systems, Inc.
2605 Fernbrook La
Minneapolis,  MN  55447
Correspondent Contact GREGORY J MATHISON
Regulation Number874.4770
Classification Product Code
ERA  
Date Received04/20/1993
Decision Date 12/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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