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FDA 510(k)

AVATRON UNIVERSAL ADULT VOL. VENTILATOR

K-Number: K842778 · 1984-07-26

ApplicantAvatron, Inc.
Decision Date1984-07-26
Product CodeBZO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AVATRON UNIVERSAL ADULT VOL. VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Avatron, Inc.. It received FDA 510(k) clearance on 1984-07-26 under 510(k) number K842778. The device is classified under product code BZO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVATRON UNIVERSAL ADULT VOL. VENTILATOR?

AVATRON UNIVERSAL ADULT VOL. VENTILATOR is a medical device that received FDA 510(k) clearance on 1984-07-26. The listed applicant is Avatron, Inc.. The 510(k) number is K842778.

When did AVATRON UNIVERSAL ADULT VOL. VENTILATOR receive FDA 510(k) clearance?

AVATRON UNIVERSAL ADULT VOL. VENTILATOR received FDA 510(k) clearance on 1984-07-26, under 510(k) number K842778.

Who is the listed applicant for AVATRON UNIVERSAL ADULT VOL. VENTILATOR?

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

What is the FDA product code for AVATRON UNIVERSAL ADULT VOL. VENTILATOR?

The FDA product code for AVATRON UNIVERSAL ADULT VOL. VENTILATOR is BZO.

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 Avatron, 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.

K851193ANESTHESIA BREATHING CIRCUITK844956AVA-MIST PORTABLE AIR COMPRESSORK843102AVA-NEB NEBULIZERK842389AVATRON DISPOSABLE I.P.P.B. CIRUCIT

Related Devices (Code: BZO)

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.

K953784UNICOR, INC. CORRUGATED TUBINGUnicor, Inc.K953785UNICOR, INC. VENTILATOR HOSESUnicor, Inc.K952011PRIMA BREATHING BAGSPrima, Inc.K952022PRIMA VOLUMN VENTILATORSSPrima, Inc.K952010PRIMA VENTILATOR HOSESPrima, Inc.K952012PRIMA CUSTOM ANESTESIA CIRCUITPrima, 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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