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510(k) K961404

Device
MX960 REUSABLE PRESSURE TRANSDUCER
Applicant
MEDEX, INC.
510(k) number
K961404
Product code
DRS  
Decision
Substantially Equivalent (SESE)
Decision date
1996-06-27
Date received
1996-04-11
Regulation
870.2850
Classification name
Transducer, Blood-pressure, Extravascular
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN C TOOMEY
Address
6250 Shier Rings Rd. Dublin OH US 40316 40316

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DRS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC2025-03-21
K221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte. , Ltd.2023-03-17
K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.2017-11-09
K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.2017-05-24
K161408Compass Cast and MAPCenturion Medical Products Corporation2016-11-22
K152472Disposable Pressure TransducerZhejiang Haisheng Medical Device Co., Ltd.2016-10-31
K152980Flo Trac sensor, Volume View sensorEdwards Lifesciences, LLC2016-01-19
K151040Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable TransducerBiometrix , Ltd.2015-09-04
K133624COMPASS CT, COMPASS CT PORTMirador Biomedical2014-04-18
K123095MEDLINE BLOOD PRESSURE TRANSDUCERMedline Industries, Inc.2013-05-08
K120624ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)Elcam Medical Acal2012-06-08
K112203COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSISTMirador Biomedical, Inc.2011-12-14
K102033COMBITRANS MONITORING SETS AND ACCESSORIESB.Braun Melsungen AG2011-04-07
K103715COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSUREMirador Biomedical, Inc.2011-01-20
K101189REAVILLMED PRESSURE MONITORING SYSTEM AND PICCReavillmed2010-12-22

Legacy Summary#

summary

FDA Review#

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