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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nystagmograph
510(k) Number K823459
Device Name PHILLY BOLT ADULT PROCEDURE KIT
Applicant
Philadelphia Medical Specialties
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Philadelphia Medical Specialties
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number882.1460
Classification Product Code
GWN  
Date Received11/18/1982
Decision Date 12/22/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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