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FDA 510(k)

FLUSH SOLUTION CONCENTRATE-BLOOD GAS

K-Number: K840300 · 1984-03-23

ApplicantBionostics, Inc.
Decision Date1984-03-23
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FLUSH SOLUTION CONCENTRATE-BLOOD GAS is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K840300. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUSH SOLUTION CONCENTRATE-BLOOD GAS?

FLUSH SOLUTION CONCENTRATE-BLOOD GAS is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Bionostics, Inc.. The 510(k) number is K840300.

When did FLUSH SOLUTION CONCENTRATE-BLOOD GAS receive FDA 510(k) clearance?

FLUSH SOLUTION CONCENTRATE-BLOOD GAS received FDA 510(k) clearance on 1984-03-23, under 510(k) number K840300.

Who is the listed applicant for FLUSH SOLUTION CONCENTRATE-BLOOD GAS?

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

What is the FDA product code for FLUSH SOLUTION CONCENTRATE-BLOOD GAS?

The FDA product code for FLUSH SOLUTION CONCENTRATE-BLOOD GAS is CHL.

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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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