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FDA 510(k)

CLARISSA INFANT NCPAP CANNULA

K-Number: K032922 · 2004-09-22

ApplicantAirways Ltd., Inc.
Decision Date2004-09-22
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CLARISSA INFANT NCPAP CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Airways Ltd., Inc.. It received FDA 510(k) clearance on 2004-09-22 under 510(k) number K032922. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLARISSA INFANT NCPAP CANNULA?

CLARISSA INFANT NCPAP CANNULA is a medical device that received FDA 510(k) clearance on 2004-09-22. The listed applicant is Airways Ltd., Inc.. The 510(k) number is K032922.

When did CLARISSA INFANT NCPAP CANNULA receive FDA 510(k) clearance?

CLARISSA INFANT NCPAP CANNULA received FDA 510(k) clearance on 2004-09-22, under 510(k) number K032922.

Who is the listed applicant for CLARISSA INFANT NCPAP CANNULA?

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

What is the FDA product code for CLARISSA INFANT NCPAP CANNULA?

The FDA product code for CLARISSA INFANT NCPAP CANNULA is CBK.

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 Airways Ltd., 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.

K951944NASALFLAIR

Related Devices (Code: CBK)

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.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.

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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