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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter, Reprocessed
510(k) Number K041127
Device Name MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS
Applicant
STERILMED, INC.
11400 73RD AVE. NORTH
MINNEAPOLIS,  MN  55369
Applicant Contact BRUCE LESTER
Correspondent
STERILMED, INC.
11400 73RD AVE. NORTH
MINNEAPOLIS,  MN  55369
Correspondent Contact BRUCE LESTER
Regulation Number870.2700
Classification Product Code
NLF  
Date Received04/30/2004
Decision Date 09/23/2004
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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