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510(k) K201666

SINGLE USE MANOMETER by Flexicare Medical Limited. — Product Code CAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2020
Date Received
June 19, 2020
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

  • 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)
  • K103639 — VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (V (September 15, 2011)