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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 K880672
Device Name SENTINEL PULSE OXIMETER
Applicant
Sentinel Monitoring Technologies, Ltd.
8765 Guion Rd. Suite E
Indianapolis,  IN  46268
Applicant Contact JERRY W JARRARD
Correspondent
Sentinel Monitoring Technologies, Ltd.
8765 Guion Rd. Suite E
Indianapolis,  IN  46268
Correspondent Contact JERRY W JARRARD
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/19/1988
Decision Date 05/06/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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