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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calculator, predicted values, pulmonary function
510(k) Number K090722
Device Name SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
Applicant
SHAPE MEDICAL SYSTEMS, INC
1313 5TH AVE. SE
SUITE 205
minneapolis,  MN  55414
Applicant Contact clarence johnson
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
twinsburg,  OH  44087
Correspondent Contact daniel w lehtonen
Regulation Number868.1890
Classification Product Code
BTY  
Date Received03/19/2009
Decision Date 03/31/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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