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)

OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M

K-Number: K053407 · 2006-04-05

ApplicantAnalytical Industries, Inc.
Decision Date2006-04-05
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M is the device name listed in this FDA 510(k) record. The listed applicant is Analytical Industries, Inc.. It received FDA 510(k) clearance on 2006-04-05 under 510(k) number K053407. 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 OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M?

OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M is a medical device that received FDA 510(k) clearance on 2006-04-05. The listed applicant is Analytical Industries, Inc.. The 510(k) number is K053407.

When did OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M receive FDA 510(k) clearance?

OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M received FDA 510(k) clearance on 2006-04-05, under 510(k) number K053407.

Who is the listed applicant for OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M?

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

What is the FDA product code for OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M?

The FDA product code for OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M is CCL.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Analytical Industries, 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.

K002382'ALL 2000' % OXYGEN ANALYZERK952736PERCENT OXYGEN SENSOR

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.

↑