FDA.report

510(k) K930888

Device
WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM
Applicant
RALIN MEDICAL, INC.
510(k) number
K930888
Product code
DRS  
Decision
Substantially Equivalent (SESE)
Decision date
1993-07-21
Date received
1993-02-19
Regulation
870.2850
Classification name
Transducer, Blood-pressure, Extravascular
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
DONALD OWEN
Address
8320 SW Nimbus Ave. Bldg. 2 Beaverton OR US 97005 97005

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Other 510(k) Records For Product Code DRS  

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

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FDA Review

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