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FDA 510(k)

PROVENT PROFESSIONAL SLEEP APNEA THERAPY

K-Number: K090398 · 2009-04-03

ApplicantVentus Medical, Inc.
Decision Date2009-04-03
Product CodeOHP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROVENT PROFESSIONAL SLEEP APNEA THERAPY is the device name listed in this FDA 510(k) record. The listed applicant is Ventus Medical, Inc.. It received FDA 510(k) clearance on 2009-04-03 under 510(k) number K090398. The device is classified under product code OHP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROVENT PROFESSIONAL SLEEP APNEA THERAPY?

PROVENT PROFESSIONAL SLEEP APNEA THERAPY is a medical device that received FDA 510(k) clearance on 2009-04-03. The listed applicant is Ventus Medical, Inc.. The 510(k) number is K090398.

When did PROVENT PROFESSIONAL SLEEP APNEA THERAPY receive FDA 510(k) clearance?

PROVENT PROFESSIONAL SLEEP APNEA THERAPY received FDA 510(k) clearance on 2009-04-03, under 510(k) number K090398.

Who is the listed applicant for PROVENT PROFESSIONAL SLEEP APNEA THERAPY?

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

What is the FDA product code for PROVENT PROFESSIONAL SLEEP APNEA THERAPY?

The FDA product code for PROVENT PROFESSIONAL SLEEP APNEA THERAPY is OHP.

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 Ventus 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.

K120665INVENT SNORING DEVICEK102404PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)K080983PROVENT NASAL CANNULAK071560PROVENT NASAL DILATOR, MODEL BR2

Related Devices (Code: OHP)

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.

K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLCK180619BongoInnomed Healthscience, Inc.K102404PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)Ventus Medical, Inc.K071560PROVENT NASAL DILATOR, MODEL BR2Ventus Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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