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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K982132
Device Name BLEASE 6200 ANAESTHESIA VENTILATOR
Applicant
BLEASE MEDICAL EQUIPMENT LTD.
12601 RESEARCH PKWY.
ATT: FRANCIS X CASEY
ORLANDO,  FL  32826
Applicant Contact FRANCIS X CASEY
Correspondent
BLEASE MEDICAL EQUIPMENT LTD.
12601 RESEARCH PKWY.
ATT: FRANCIS X CASEY
ORLANDO,  FL  32826
Correspondent Contact FRANCIS X CASEY
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/17/1998
Decision Date 04/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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