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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 K042616
FOIA Releasable 510(k) K042616
Device Name BIOMEDIX PADNET LAB
Applicant
Biomedix, Inc.
4205 White Bear Pkwy.
St. Paul,  MN  55110
Applicant Contact WILLIAM ROGERS
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Regulation Number870.2780
Classification Product Code
JOM  
Date Received09/23/2004
Decision Date 10/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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