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FDA 510(k)

CARBON DIOXIDE CALIBRATOR I

K-Number: K840774 · 1984-04-04

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

Device Summary

CARBON DIOXIDE CALIBRATOR I 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 K840774. 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 I?

CARBON DIOXIDE CALIBRATOR I 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 K840774.

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

CARBON DIOXIDE CALIBRATOR I received FDA 510(k) clearance on 1984-04-04, under 510(k) number K840774.

Who is the listed applicant for CARBON DIOXIDE CALIBRATOR I?

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 I?

The FDA product code for CARBON DIOXIDE CALIBRATOR I 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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