Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Accu O2 Oxygen Analyzer

K-Number: K173807 · 2018-05-02

ApplicantPrecision Medical, Inc.
Decision Date2018-05-02
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Accu O2 Oxygen Analyzer 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 2018-05-02 under 510(k) number K173807. 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 Accu O2 Oxygen Analyzer?

Accu O2 Oxygen Analyzer is a medical device that received FDA 510(k) clearance on 2018-05-02. The listed applicant is Precision Medical, Inc.. The 510(k) number is K173807.

When did Accu O2 Oxygen Analyzer receive FDA 510(k) clearance?

Accu O2 Oxygen Analyzer received FDA 510(k) clearance on 2018-05-02, under 510(k) number K173807.

Who is the listed applicant for Accu O2 Oxygen Analyzer?

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 Accu O2 Oxygen Analyzer?

The FDA product code for Accu O2 Oxygen Analyzer is CCL.

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.

↑