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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 K922428
Device Name FUKUDA DENSHI MODEL SPIROSIFT SP-5000
Applicant
FUKUDA DENSHI USA, INC.
7102-A 180TH AVENUE NORTHEAST
REDMOND,  WA  98052
Applicant Contact DAVID J GERAGHTY
Correspondent
FUKUDA DENSHI USA, INC.
7102-A 180TH AVENUE NORTHEAST
REDMOND,  WA  98052
Correspondent Contact DAVID J GERAGHTY
Regulation Number868.1840
Classification Product Code
BZG  
Date Received05/22/1992
Decision Date 01/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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