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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Apnea, Facility Use
510(k) Number K962865
Device Name REMBRANDT SYSTEM
Applicant
Airsep Corp.
290 Creekside Dr.
Buffalo,  NY  14228
Applicant Contact RAVI K BANSAL
Correspondent
Airsep Corp.
290 Creekside Dr.
Buffalo,  NY  14228
Correspondent Contact RAVI K BANSAL
Regulation Number868.2377
Classification Product Code
FLS  
Date Received07/23/1996
Decision Date 10/25/1996
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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