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510(k) K880967

MICRO CO2 APPARATUS by Hf Scientific, Inc. — Product Code CIE

K880967 is an FDA 510(k) premarket notification submitted by Hf Scientific, Inc. for the device "MICRO CO2 APPARATUS". The FDA issued a decision of Substantially Equivalent on April 28, 1988. The device falls under product code CIE (Volumetric/Manometric, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Hf Scientific, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1988
Date Received
March 8, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Volumetric/Manometric, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type

Other clearances by Hf Scientific, Inc.

  • K882801 — RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN. (August 29, 1988)
  • K874429 — HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 (February 4, 1988)
  • K864313 — CO2 REAGENT SET (March 13, 1987)
  • K864862 — REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA. (February 20, 1987)

Other clearances for product code CIE

  • K904761 — P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT (November 20, 1990)
  • K864313 — CO2 REAGENT SET (March 13, 1987)
  • K832071 — TOTAL CO2 REAGENT SET (August 11, 1983)
  • K820091 — AIRMED SMOKE EVACUATION & FILTER (February 24, 1982)
  • K800524 — SERALYZER REFLECTANCE PHOTOMETER/CALIB. (April 2, 1980)
  • K771610 — CARBON DIOXIDE ANALYZER (October 7, 1977)

FDA data resources