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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Head, Radiographic
510(k) Number K884493
Device Name HEAD HOLDING DEVICE/SLEEP APNEA
Applicant
X-Ray Systems
33061 Groesbeck Hwy.
Fraser,  MI  48026
Applicant Contact RICHARD C DRUMB
Correspondent
X-Ray Systems
33061 Groesbeck Hwy.
Fraser,  MI  48026
Correspondent Contact RICHARD C DRUMB
Regulation Number892.1920
Classification Product Code
IWY  
Date Received10/26/1988
Decision Date 01/12/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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