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510(k) K931542

NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR by Newport Medical Instruments, Inc. — Product Code BZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1993
Date Received
March 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Monitoring (W/Wo Alarm)
Device Class
Class II
Regulation Number
868.1850
Review Panel
AN
Submission Type

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  • K030780 — NEWPORT E500 WAVE VENTILATOR (January 23, 2004)

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