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FDA 510(k)

CARBON DIOXIDE CALIBRATOR II

K-Number: K840775 · 1984-04-04

ApplicantAmerican Dade
Decision Date1984-04-04
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARBON DIOXIDE CALIBRATOR II is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1984-04-04 under 510(k) number K840775. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARBON DIOXIDE CALIBRATOR II?

CARBON DIOXIDE CALIBRATOR II is a medical device that received FDA 510(k) clearance on 1984-04-04. The listed applicant is American Dade. The 510(k) number is K840775.

When did CARBON DIOXIDE CALIBRATOR II receive FDA 510(k) clearance?

CARBON DIOXIDE CALIBRATOR II received FDA 510(k) clearance on 1984-04-04, under 510(k) number K840775.

Who is the listed applicant for CARBON DIOXIDE CALIBRATOR II?

The FDA 510(k) record lists American Dade as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARBON DIOXIDE CALIBRATOR II?

The FDA product code for CARBON DIOXIDE CALIBRATOR II is JIT.

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Related Devices (Code: JIT)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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