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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 K071462
Device Name UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
Applicant
Siemens Hearing Instruments, Inc.
10 Constitution Ave.
P.O. Box 1397
Piscataway,  NJ  08855
Applicant Contact JON SCHIRADO
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number874.3310
Classification Product Code
ETW  
Date Received05/25/2007
Decision Date 06/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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