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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 K952315
Device Name SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE
Applicant
Emg Scientific
1461 S. Livonia
Los Angeles,  CA  90035
Applicant Contact SHMUEL EINSTEIN
Correspondent
Emg Scientific
1461 S. Livonia
Los Angeles,  CA  90035
Correspondent Contact SHMUEL EINSTEIN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/17/1995
Decision Date 12/04/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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