LCH — Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical Class I

FDA Device Classification

Classification Details

Product Code
LCH
Device Class
Class I
Regulation Number
862.1660
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K922386bionosticsRNA MEDICAL TONOMETERJune 26, 1992
K904163norcoCLINICAL BLOOD GAS MIXTURESNovember 1, 1990
K900819cryogenic rare gas laboratoriesBLOOD GAS CALIBRATION STANDARDApril 25, 1990
K862958associated medical representativesAMR RESEARCH TONOMETERNovember 24, 1986
K841089linear tonometersLINEAR CLOUD TONOMETERMay 22, 1984
K802379american instrumentHEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZEROctober 31, 1980
K801599corning medical and scientificCORNING 184 BLOOD GAS TONOMETERAugust 20, 1980
K781417medicor usaPRECISION GAS MIXERSeptember 20, 1978
K781386equilibrated bio systemsEBS 775 TONOMETERSeptember 14, 1978