DRQ — Amplifier And Signal Conditioner, Transducer Signal Class II

FDA Device Classification

Classification Details

Product Code
DRQ
Device Class
Class II
Regulation Number
870.2060
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K172216acist medical systemsACIST RXi Mini SystemAugust 18, 2017
K152693boston scientific corporationCLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGOctober 21, 2015
K150235boston scientific corporationCLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSApril 22, 2015
K050006c.r. bardBOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHMay 27, 2005
K050974draeger medical systemsDRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERSApril 29, 2005
K033807draeger medical systemsINFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTERMarch 9, 2004
K013205millar instrumentsMILLAR PRESSURE CONTROL UNIT MODEL PCU-2000July 2, 2002
K020277siemens medical solutions usaSIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTERFebruary 19, 2002
K010640siemens medical solutions usaSIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTERMarch 20, 2001
K913875bard electrophysiologyBARD(R) BIOPOTENTIAL AMPLIFIER IINovember 27, 1991
K913110microwave medical systemsPDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIEDOctober 10, 1991
K910905life sciences manufacturingSFA-II MICROPROCESSOR-CONTROLLED MODULEJuly 24, 1991
K904749transtracheal systemsTRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200March 1, 1991
K901358c.r. bardBARD BIOPOTENTIAL AMPLIFIER IIMay 9, 1990
K894295astro-medASTRO-MED ASC-951 PRESSURE PROCESSORJanuary 18, 1990
K885252ep technologiesMAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001January 13, 1989
K870783fisher imagingBPA CARDIOVASCULAR PRESSURE AMPLIFIERApril 27, 1987
K870728a and d engineeringTAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701March 27, 1987
K864320cordisSENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACEFebruary 20, 1987
K830914honeywellEXTERNAL VALVE FUNCTION BLOCKAugust 12, 1983