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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 K920322
Device Name OPTIEAR
Applicant
Nankivell Industries, Inc.
670 Arroyo Ave.
San Fernando,  CA  91340
Applicant Contact NANKIVELL
Correspondent
Nankivell Industries, Inc.
670 Arroyo Ave.
San Fernando,  CA  91340
Correspondent Contact NANKIVELL
Regulation Number874.4770
Classification Product Code
ERA  
Date Received01/24/1992
Decision Date 04/23/1992
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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