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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K941162
Device Name HYPERGRAPH
Applicant
Dermed Diagnostics, Inc.
2-S 558 White Birch Ln.
Wheaton,  IL  60187
Applicant Contact ARTHUR P DEMARZO
Correspondent
Dermed Diagnostics, Inc.
2-S 558 White Birch Ln.
Wheaton,  IL  60187
Correspondent Contact ARTHUR P DEMARZO
Regulation Number870.2770
Classification Product Code
DSB  
Date Received03/11/1994
Decision Date 12/15/1994
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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