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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number K851128
Device Name DIGITMATIC DM2
Applicant
Medimatic
18103 Sky Park S. D-205
Irvine,  CA  92714
Applicant Contact JORGEN MADSEN
Correspondent
Medimatic
18103 Sky Park S. D-205
Irvine,  CA  92714
Correspondent Contact JORGEN MADSEN
Regulation Number870.2780
Classification Product Code
JOM  
Date Received03/20/1985
Decision Date 07/19/1985
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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