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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Hearing Aid / Earphone And Analysis Systems
510(k) Number K862026
Device Name HA-2000 REAL EAR SPECTROSCOPE
Applicant
And/Or Corp.
2801 Youngfield, Suite 110
Golden,  CO  80401
Applicant Contact CHARLIE D ANDERSON
Correspondent
And/Or Corp.
2801 Youngfield, Suite 110
Golden,  CO  80401
Correspondent Contact CHARLIE D ANDERSON
Regulation Number874.3310
Classification Product Code
ETW  
Date Received05/28/1986
Decision Date 08/15/1986
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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