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FDA 510(k)

PRECISION OXYGEN MONITOR

K-Number: K063096 · 2007-02-27

ApplicantPrecision Medical, Inc.
Decision Date2007-02-27
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRECISION OXYGEN MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Precision Medical, Inc.. It received FDA 510(k) clearance on 2007-02-27 under 510(k) number K063096. 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 PRECISION OXYGEN MONITOR?

PRECISION OXYGEN MONITOR is a medical device that received FDA 510(k) clearance on 2007-02-27. The listed applicant is Precision Medical, Inc.. The 510(k) number is K063096.

When did PRECISION OXYGEN MONITOR receive FDA 510(k) clearance?

PRECISION OXYGEN MONITOR received FDA 510(k) clearance on 2007-02-27, under 510(k) number K063096.

Who is the listed applicant for PRECISION OXYGEN MONITOR?

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

What is the FDA product code for PRECISION OXYGEN MONITOR?

The FDA product code for PRECISION OXYGEN MONITOR is CCL.

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Other records listing Precision Medical, Inc. as applicant

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.

K173807Accu O2 Oxygen AnalyzerK103563PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150K103324PRECISION LIQUID OXYGEN SYSTEMK090781HELIO2 BLENDERK072348PRECISION OXYGEN CONCENTRATORK053232PRECISION BLENDER

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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

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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