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FDA 510(k)

FLOWMETER, OPTIFLO GAS

K-Number: K790546 · 1979-05-11

ApplicantCobe Laboratories, Inc.
Decision Date1979-05-11
Product CodeDTX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLOWMETER, OPTIFLO GAS is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1979-05-11 under 510(k) number K790546. 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 FLOWMETER, OPTIFLO GAS?

FLOWMETER, OPTIFLO GAS is a medical device that received FDA 510(k) clearance on 1979-05-11. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K790546.

When did FLOWMETER, OPTIFLO GAS receive FDA 510(k) clearance?

FLOWMETER, OPTIFLO GAS received FDA 510(k) clearance on 1979-05-11, under 510(k) number K790546.

Who is the listed applicant for FLOWMETER, OPTIFLO GAS?

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

What is the FDA product code for FLOWMETER, OPTIFLO GAS?

The FDA product code for FLOWMETER, OPTIFLO GAS is DTX.

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Other records listing Cobe Laboratories, Inc. as applicant

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Related Devices (Code: DTX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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