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)

MALLARD AIR OXYGEN ACCUBLENDER

K-Number: K001609 · 2000-08-10

ApplicantMallard Medical, Inc.
Decision Date2000-08-10
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MALLARD AIR OXYGEN ACCUBLENDER is the device name listed in this FDA 510(k) record. The listed applicant is Mallard Medical, Inc.. It received FDA 510(k) clearance on 2000-08-10 under 510(k) number K001609. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MALLARD AIR OXYGEN ACCUBLENDER?

MALLARD AIR OXYGEN ACCUBLENDER is a medical device that received FDA 510(k) clearance on 2000-08-10. The listed applicant is Mallard Medical, Inc.. The 510(k) number is K001609.

When did MALLARD AIR OXYGEN ACCUBLENDER receive FDA 510(k) clearance?

MALLARD AIR OXYGEN ACCUBLENDER received FDA 510(k) clearance on 2000-08-10, under 510(k) number K001609.

Who is the listed applicant for MALLARD AIR OXYGEN ACCUBLENDER?

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

What is the FDA product code for MALLARD AIR OXYGEN ACCUBLENDER?

The FDA product code for MALLARD AIR OXYGEN ACCUBLENDER is BZR.

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 Mallard 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.

K033026MALLARD MODEL 3000 ANESTHESIA MACHINE

Related Devices (Code: BZR)

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.

K243917F&P Optiflow Air/Oxygen Flow SourceFisher & Paykel Healthcare, Ltd.K241465Midas Flowmeter; eAVSParker Hannifin CorporationK231895Maxtec MaxBlend2+pMaxtec, LLCK230987FlowStar Analog Mixer FlowmeterBaldus Sedation GmbH & Co. KGK222794FlowStar Touch Digital Mixer FlowmeterBaldus Sedation GmbH & Co. KGK221494Quality Mix Blender, OxymixerDehas Medical Systems GmbH

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.

↑