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510(k) K140370

DISPOSABLE PRESSURE MANOMETER by Besmed Health Business Corp — Product Code CAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2014
Date Received
February 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Device Class
Class II
Regulation Number
868.2600
Review Panel
AN
Submission Type

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Other clearances for product code CAP

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  • K122627 — GIO DIGITAL PRESSURE GUAGES (August 22, 2013)
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  • K120118 — VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER (May 24, 2012)
  • K103639 — VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (V (September 15, 2011)