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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 K971336
Device Name CAIRD TECHNOLOGY SPIROMETER
Applicant
CAIRD TECHNOLOGY
205 CAMDEN CHASE
COLUMBIA,  SC  29223
Applicant Contact JAMES H BROWN
Correspondent
CAIRD TECHNOLOGY
205 CAMDEN CHASE
COLUMBIA,  SC  29223
Correspondent Contact JAMES H BROWN
Regulation Number868.1840
Classification Product Code
BZG  
Date Received04/10/1997
Decision Date 12/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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