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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K827087
Device Name P1808 MOBILE C-ARM IMAGE INTENSIFIER
Applicant
Precise Optics
239 S. Fehr Way
Bay Shore,  NY  11706
Correspondent
Precise Optics
239 S. Fehr Way
Bay Shore,  NY  11706
Date Received01/22/1982
Decision Date 03/04/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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