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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K945464
Device Name FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE
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 Number870.2700
Classification Product Code
DQA  
Date Received11/07/1994
Decision Date 02/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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