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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K862962
Device Name APNET RESPIRATION MONITOR
Applicant
WIRELESS MONITORS, INC.
59 FAR POND RD.
SOUTHAMPTON,  NY  11968
Applicant Contact MICHAEL SCIARRA
Correspondent
WIRELESS MONITORS, INC.
59 FAR POND RD.
SOUTHAMPTON,  NY  11968
Correspondent Contact MICHAEL SCIARRA
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received08/06/1986
Decision Date 09/19/1986
Decision Substantially Equivalent (SESE)
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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