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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 K001553
Device Name BREAS PV 100 CPAP SYSTEM
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 Received05/18/2000
Decision Date 08/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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