FDA.reportPublic FDA data

510(k) K201666

Device
SINGLE USE MANOMETER
Applicant
Flexicare Medical Limited.
510(k) number
K201666
Product code
CAP
Decision
Substantially Equivalent (SESE)
Decision date
2020-11-13
Date received
2020-06-19
Regulation
868.2600
Classification name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Joel Biddle
Address
Cynon Valley Business Park Mountain Ash GB CF45 4ER CF45 4ER

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CAP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc.2019-09-18
K180510NS 120P-TRS Airway Pressure GaugeInstrumentation Industries, Inc.2019-05-01
K172284NAPA LP-15 Airway Pressure MonitorDrw Medical, LLC2018-02-09
K153733VORTRAN ManometerVortran Medical Technology 1, Inc.2016-09-16
K143148Disposable Pressure Manometer (DPM)Westmed, Inc.2015-08-11
K140370DISPOSABLE PRESSURE MANOMETERBesmed Health Business Corp2014-06-19
K122627GIO DIGITAL PRESSURE GUAGESGalemed Corp.2013-08-22
K122077MANOMETERIntersurgical, Inc.2013-01-10
K120118VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETERVentlab Corp.2012-05-24
K103639VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRICVortran Medical Technology 1, Inc.2011-09-15
K110119PRESSURE MANOMETERNeoforce Group, Inc.2011-06-10
K102377VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0A Plus Medical2010-11-18
K081778NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORSInstrumentation Industries, Inc.2008-09-12
K050309PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000Viasys Medsystems2005-03-25
K040991AMBU DISPOSABLE PRESSURE MANOMETERAmbu, Inc.2004-07-22