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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K920844
Device Name PIM 1.0 LASER DOPPLER PERFUSION IMAGER
Applicant
Lisca Development AB
Lovsbergsv. 13
Linkoping,  SE
Applicant Contact GERT NILSSON
Correspondent
Lisca Development AB
Lovsbergsv. 13
Linkoping,  SE
Correspondent Contact GERT NILSSON
Regulation Number870.2100
Classification Product Code
DPW  
Date Received02/24/1992
Decision Date 07/21/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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