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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 K011974
Device Name SENSAID
Applicant
Sensidyne, Inc.
16333 Bay Vista Dr.
Clearwater,  FL  33760
Applicant Contact GEORGE MASON
Correspondent
Sensidyne, Inc.
16333 Bay Vista Dr.
Clearwater,  FL  33760
Correspondent Contact GEORGE MASON
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/25/2001
Decision Date 02/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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