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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 K910077
Device Name CRIT-SCAN
Applicant
NONINVASIVE MEDICAL TECHNOLOGY CORP.
333 SECOND STREET, SUITE 8
OGDEN,  UT  84404
Applicant Contact ROBERT R STEUER
Correspondent
NONINVASIVE MEDICAL TECHNOLOGY CORP.
333 SECOND STREET, SUITE 8
OGDEN,  UT  84404
Correspondent Contact ROBERT R STEUER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/09/1991
Decision Date 06/02/1992
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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