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FDA 510(k)

DIGIFLO CONCENTRATOR ANALYZER

K-Number: K072469 · 2008-01-03

ApplicantDigiflo, Inc.
Decision Date2008-01-03
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DIGIFLO CONCENTRATOR ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Digiflo, Inc.. It received FDA 510(k) clearance on 2008-01-03 under 510(k) number K072469. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGIFLO CONCENTRATOR ANALYZER?

DIGIFLO CONCENTRATOR ANALYZER is a medical device that received FDA 510(k) clearance on 2008-01-03. The listed applicant is Digiflo, Inc.. The 510(k) number is K072469.

When did DIGIFLO CONCENTRATOR ANALYZER receive FDA 510(k) clearance?

DIGIFLO CONCENTRATOR ANALYZER received FDA 510(k) clearance on 2008-01-03, under 510(k) number K072469.

Who is the listed applicant for DIGIFLO CONCENTRATOR ANALYZER?

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

What is the FDA product code for DIGIFLO CONCENTRATOR ANALYZER?

The FDA product code for DIGIFLO CONCENTRATOR ANALYZER is CCL.

Related Clinical Trials

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Related Devices (Code: CCL)

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.

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter LabsK251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLCK221734Maxtec MaxO2 ME+pMaxtec, LLCK213933Percent Oxygen SensorsCareox, LLCK213948OxyMinderBio-Med Devices, Inc.

Official Source

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

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