FDA.report

510(k) K902627

Device
Interflo Medical Model Oxi/co Fila. Thermo. Cath.
Applicant
BIOMETRIC RESEARCH INSTITUTE, INC.
510(k) number
K902627
Product code
KRB
Decision
Substantially Equivalent (SESE)
Decision date
1991-02-25
Date received
1990-06-13
Regulation
870.1915
Classification name
Probe, Thermodilution
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Related Records

Applicant Contact

Contact
A RAHMOELLER
Address
1401 Wilson Blvd. Suite 400 Arlington VA US 22209 22209

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KRB

510(k)DeviceApplicantDecision date
K171620PiCCO CatheterPulsion Medical Systems SE2018-02-21
K100739VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5Edwards Lifesciences, LLC2010-12-07
K072364PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIESPulsion Medical Systems AG2007-09-19
K020587PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046Pulsion Medical Systems AG2002-05-23
K991886PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSORPulsion Medical Systems, Inc.2000-05-11
K936182CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KITOhmeda Medical1994-03-25
K915627PACEVIEWMicromedical Industries, Ltd.1992-03-27
K912172SAFEWEDGE(TM) RELIEF VALVE DEVICESunscope Intl., Inc.1991-09-27
K900710INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETERIntec Medical, Inc.1990-10-19
K900317PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETERElecath1990-06-22
K892941CCO SYSTEM MODEL SP1467,SP5567,SP6267Spectramed, Inc.1989-11-06
K884318THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEMAbbott Laboratories1988-12-13
K881893NUMED BALLOON THERMODILUTION CATHETERNuMED, Inc.1988-09-06
K874522MODIFIED MYOCARDIAL TEMPERATURE SENSORMon-A-Therm, Inc.1988-01-29
K864818ACKRAD TDI SETAckrad Laboratories1987-04-09