FDA.reportPublic FDA data

510(k) K771116

Device
CATHETER, PO2, INTRAVASUCLAR, CITADEL
Applicant
Sherwood Medical Industries
510(k) number
K771116
Product code
CCE
Decision
Substantially Equivalent (SESE)
Decision date
1977-09-15
Date received
1977-06-16
Regulation
868.1200
Classification name
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Third party reviewed
N

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CCE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K935778VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEMVia Medical Corp.1996-12-05
K912145SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIAS & W Medico Teknik1992-05-05
K910453TOPS NEEDLE TIP PROBE & PVC TIP PROBEBaxter Healthcare Corp1991-08-13
K905397PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEMPuritan Bennett Corp.1991-05-14
K896311OPTEX BLOOD GAS MONITORING SYSTEMOptex Biomedical1990-01-03
K890624TISSUE OXYGEN MONITOR SYSTEM, MODEL IIBaxter Healthcare Corp1989-12-22
K895150CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORINGShiley, Inc.1989-11-28
K895149NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SYShiley, Inc.1989-11-28
K884063BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEMC.R. Bard, Inc.1988-12-16
K875225UMBILICAL ARTERY OXYGEN SENSOROhmeda Medical1988-03-04
K872896UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100American Bentley1988-02-12
K872125BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEMC.R. Bard, Inc.1987-12-11
K860808CONTINUCATHOrange Medical Instruments, Inc.1986-03-13
K860106OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100American Bentley1986-02-26
K853786OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100American Bentley1985-10-16