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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
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