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510(k) K050309

PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 by Viasys Medsystems — Product Code CAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2005
Date Received
February 8, 2005
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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  • K043044 — ANTI-I.V. ENTERAL FEEDING SYSTEM (May 6, 2005)
  • K043004 — STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12 (March 16, 2005)
  • K041987 — CORTRAK (December 17, 2004)

Other clearances for product code CAP

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  • K182292 — VORTRAN APM-Plus (September 18, 2019)
  • K180510 — NS 120P-TRS Airway Pressure Gauge (May 1, 2019)
  • K172284 — NAPA LP-15 Airway Pressure Monitor (February 9, 2018)
  • K153733 — VORTRAN Manometer (September 16, 2016)
  • K143148 — Disposable Pressure Manometer (DPM) (August 11, 2015)
  • K140370 — DISPOSABLE PRESSURE MANOMETER (June 19, 2014)
  • K122627 — GIO DIGITAL PRESSURE GUAGES (August 22, 2013)
  • K122077 — MANOMETER (January 10, 2013)
  • K120118 — VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER (May 24, 2012)