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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
510(k) Number K844781
Device Name MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB
Applicant
Shaban Mfg. Co.
3052 Metro Pkwy.
Fort Myers,  FL  33901
Applicant Contact BARBARA H SNEADE
Correspondent
Shaban Mfg. Co.
3052 Metro Pkwy.
Fort Myers,  FL  33901
Correspondent Contact BARBARA H SNEADE
Regulation Number862.1120
Classification Product Code
CHL  
Date Received12/10/1984
Decision Date 02/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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