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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K001995
Device Name SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER
Applicant
QRS DIAGNOSTIC, LLC.
14755 27TH AVE.NORTH
PLYMOUTH,  MN  55447
Applicant Contact JILL R KRALL
Correspondent
QRS DIAGNOSTIC, LLC.
14755 27TH AVE.NORTH
PLYMOUTH,  MN  55447
Correspondent Contact JILL R KRALL
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
BZQ  
Date Received06/30/2000
Decision Date 09/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
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