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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Patient Position, Light-Beam
510(k) Number K943381
Device Name LASER ALIGNMENT TOOL
Applicant
Philips Medical Systems North America, Inc.
710 Bridgeport Ave.
Shelton,  CT  06484
Applicant Contact TIMOTHY W CAPEHART
Correspondent
Philips Medical Systems North America, Inc.
710 Bridgeport Ave.
Shelton,  CT  06484
Correspondent Contact TIMOTHY W CAPEHART
Regulation Number892.5780
Classification Product Code
IWE  
Date Received07/13/1994
Decision Date 08/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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