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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 K954267
Device Name BURDICK 200 PULSE OXIMETER
Applicant
BURDICK, INC.
15 PLUMB ST.
MILTON,  WI  53563 -1499
Applicant Contact PAUL E APPEL
Correspondent
BURDICK, INC.
15 PLUMB ST.
MILTON,  WI  53563 -1499
Correspondent Contact PAUL E APPEL
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/12/1995
Decision Date 05/03/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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