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FDA 510(k)

GAS-FLOW METER GFL 10

K-Number: K822820 · 1982-10-18

ApplicantGambro, Inc.
Decision Date1982-10-18
Product CodeDTX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GAS-FLOW METER GFL 10 is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1982-10-18 under 510(k) number K822820. The device is classified under product code DTX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAS-FLOW METER GFL 10?

GAS-FLOW METER GFL 10 is a medical device that received FDA 510(k) clearance on 1982-10-18. The listed applicant is Gambro, Inc.. The 510(k) number is K822820.

When did GAS-FLOW METER GFL 10 receive FDA 510(k) clearance?

GAS-FLOW METER GFL 10 received FDA 510(k) clearance on 1982-10-18, under 510(k) number K822820.

Who is the listed applicant for GAS-FLOW METER GFL 10?

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

What is the FDA product code for GAS-FLOW METER GFL 10?

The FDA product code for GAS-FLOW METER GFL 10 is DTX.

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Other records listing Gambro, Inc. as applicant

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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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