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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K030985
Device Name BREAS PV 10I CPAP SYSTEM, MODEL PV 10I
Applicant
Vital Signs, Inc.
20 Campus Rd.
Totowa,  NJ  07512
Applicant Contact ANTHONY P MARTINO
Correspondent
Vital Signs, Inc.
20 Campus Rd.
Totowa,  NJ  07512
Correspondent Contact ANTHONY P MARTINO
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/28/2003
Decision Date 10/15/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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