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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
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