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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K973138
Device Name SPIROCARD
Applicant
QRS DIAGNOSTIC, LLC.
14030 23RD AVE. NORTH
PLYMOUTH,  MN  55447
Applicant Contact KEVIN J DRISCOLL
Correspondent
QRS DIAGNOSTIC, LLC.
14030 23RD AVE. NORTH
PLYMOUTH,  MN  55447
Correspondent Contact KEVIN J DRISCOLL
Regulation Number868.1840
Classification Product Code
BZG  
Date Received08/21/1997
Decision Date 10/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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