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FDA 510(k)

VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR

K-Number: K895747 · 1989-10-27

ApplicantHudson Oxygen Therapy Sales Co.
Decision Date1989-10-27
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Hudson Oxygen Therapy Sales Co.. It received FDA 510(k) clearance on 1989-10-27 under 510(k) number K895747. The device is classified under product code CAP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR?

VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 1989-10-27. The listed applicant is Hudson Oxygen Therapy Sales Co.. The 510(k) number is K895747.

When did VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR receive FDA 510(k) clearance?

VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR received FDA 510(k) clearance on 1989-10-27, under 510(k) number K895747.

Who is the listed applicant for VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR?

The FDA 510(k) record lists Hudson Oxygen Therapy Sales Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR?

The FDA product code for VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR is CAP.

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 Hudson Oxygen Therapy Sales Co. 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.

K902062PEEP VALVEK900783MDI ADAPTORK900470IN-THE NEBULIZERK895589MANUAL RESUSCITATORK896136INFANT C.P.A.P. MONITORK895231CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER

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Related Devices (Code: CAP)

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.

K201666SINGLE USE MANOMETERFlexicare Medical Limited.K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc.K180510NS 120P-TRS Airway Pressure GaugeInstrumentation Industries, Inc.K172284NAPA LP-15 Airway Pressure MonitorDrw Medical, LLCK153733VORTRAN ManometerVortran Medical Technology 1, Inc.K122627GIO DIGITAL PRESSURE GUAGESGalemed Corp.

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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