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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 K897094
Device Name MODIFIED SPIROSCAN 1000
Applicant
Fukuda Denshi USA, Inc.
7102-A 180th Ave. Northeast
Redmond,  WA  98052
Applicant Contact ROBERT J STEURER
Correspondent
Fukuda Denshi USA, Inc.
7102-A 180th Ave. Northeast
Redmond,  WA  98052
Correspondent Contact ROBERT J STEURER
Regulation Number868.1840
Classification Product Code
BZG  
Date Received12/20/1989
Decision Date 01/12/1990
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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