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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 K943546
Device Name FUKUDA SANGYO MODEL SPIROANALYZER ST-180
Applicant
Spirosoft Northamerica, Inc.
2522 Chambers Rd.
Sutie 110-B
Tustin,  CA  92680
Applicant Contact RAYMOND W COHEN
Correspondent
Spirosoft Northamerica, Inc.
2522 Chambers Rd.
Sutie 110-B
Tustin,  CA  92680
Correspondent Contact RAYMOND W COHEN
Regulation Number868.1840
Classification Product Code
BZG  
Date Received07/21/1994
Decision Date 02/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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