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510(k) K122627

GIO DIGITAL PRESSURE GUAGES by Galemed Corp. — Product Code CAP

K122627 is an FDA 510(k) premarket notification submitted by Galemed Corp. for the device "GIO DIGITAL PRESSURE GUAGES". The FDA issued a decision of Substantially Equivalent on August 22, 2013. The device falls under product code CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm)), a Class II device regulated under 21 CFR 868.2600. Galemed Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2013
Date Received
August 28, 2012
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

Other clearances by Galemed Corp.

  • K132679 — AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER (April 18, 2014)
  • K133957 — DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE (April 14, 2014)
  • K082092 — DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXE (October 15, 2008)
  • K072755 — GALEMED CPAP MASK (November 16, 2007)
  • K022124 — GALEMED PEAK FLOW METER, MODELS 3751/3752 (April 3, 2003)
  • K021742 — GALEMED NEB-EASY NEBULIZER (October 25, 2002)

Other clearances for product code CAP

  • K201666 — SINGLE USE MANOMETER (November 13, 2020)
  • 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)
  • 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)

FDA data resources