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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Volumetric/Manometric, Carbon-Dioxide
510(k) Number K880967
Device Name MICRO CO2 APPARATUS
Applicant
Hf Scientific, Inc.
3052 Metro Pkwy. SE
Ft. Myers,  FL  33916
Applicant Contact BARBARA H SNEADE
Correspondent
Hf Scientific, Inc.
3052 Metro Pkwy. SE
Ft. Myers,  FL  33916
Correspondent Contact BARBARA H SNEADE
Regulation Number862.1160
Classification Product Code
CIE  
Date Received03/08/1988
Decision Date 04/28/1988
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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