Micro CO2 Apparatus

FDA 510(k) K880967 · Hf Scientific, Inc.

Substantially Equivalent

510(k) numberK880967

Submission

Device name
Micro CO2 Apparatus
Applicant
Hf Scientific, Inc.
Ft. Myers, FL, US
Received
March 8, 1988
Decision date
April 28, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CIE – Volumetric/Manometric, Carbon-Dioxide
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1160
Specialty
Clinical Chemistry

Other 510(k)s with product code CIE

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K904761P/N 35310, Il Test Alkaline Phosphatase ReagentCIE · Traditional Instrumentation Laboratory CO11/20/1990SE
K864313CO2 Reagent SetCIE · Traditional Hf Scientific, Inc.03/13/1987SE
K832071Total CO2 Reagent SetCIE · Traditional American Research Products Co.08/11/1983SE
K820091Airmed Smoke Evacuation & FilterCIE · Traditional James L. Geraci & Associates, Inc.02/24/1982SE
K800524Seralyzer Reflectance Photometer/Calib.CIE · Traditional Miles Laboratories, Inc.04/02/1980SE
K771610Carbon Dioxide AnalyzerCIE · Traditional Corning Medical & Scientific10/07/1977SE

More from Corning Medical & Scientific

510(k)DeviceDecision
K882801Rinse & Reference Solution/Buffer/Low & High Stan.JGS · Traditional 08/29/1988SE
K874429Hemoglobin Determination Test Kit HGB S-100 & 12GIQ · Traditional 02/04/1988SE
K864313CO2 Reagent SetCIE · Traditional 03/13/1987SE
K864862Ref. Membrane for Orion 1020 Sodium/Potassium Ana.JGS · Traditional 02/20/1987SE

Questions and answers

When was Micro CO2 Apparatus cleared by the FDA?

Micro CO2 Apparatus (K880967) received a 510(k) decision of Substantially Equivalent on April 28, 1988, 51 days after the submission was received.

What is the product code of K880967?

The FDA product code is CIE – Volumetric/Manometric, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.