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510(k) K842497

Device
SERVOMED OXYMONITO SMK 363
Applicant
LITTON DATAMEDIX
510(k) number
K842497
Product code
KLK  
Decision
Substantially Equivalent (SESE)
Decision date
1984-10-04
Date received
1984-06-26
Regulation
868.2500
Classification name
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KLK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K003943MICROGAS 7650 TRANSCUTANEOUS MONITORLinde Medical Sensors AG2001-05-04
K991644MICROGAS 7650 TRANSCUTANEOUS MONITORLinde Medical Sensors AG1999-05-21
K980287SIEMENS SC9000/SC9015 TCP02/C02 MODULESiemens Medical Solutions USA, Inc.1998-08-12
K924709SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETEAir-Shields, Inc.1996-01-17
K924679OXYCARE(TM) OXYGEN CONTROLLER/MONITORAir-Shields Vickers, Inc.1995-02-21
K925910HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULEHewlett-Packard Co.1993-07-29
K893133HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXXMennen Medical, Inc.1989-07-14
K870805MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITORNovametrix Medical Systems, Inc.1987-05-27
K861861515A NEO-TRAK NEONATAL MONITORGe Medical Systems Information Technologies1986-07-10
K860124HORIZON 2000 TRANSCUTANEOUS GAS MONITORINGMennen Medical, Inc.1986-05-09
K860951KONTRON CUTANEOUS PO2 MONITOR 820Kontron Instruments, Inc.1986-04-09
K852959PO-510 TCPO2 MONITORSumitomo Electric Industries, Inc.1985-11-29
K851451STAT GAS MODULEVulcan Laboratories, Inc.1985-08-02
K844253NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2Novametrix Medical Systems, Inc.1985-01-10
K844079NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGENNovametrix Medical Systems, Inc.1984-11-30

Legacy Summary#

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FDA Review#

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