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)

ADULT VENTILATOR

K-Number: K943106 · 1995-12-28

ApplicantInfrasonics Corp.
Decision Date1995-12-28
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

ADULT VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Infrasonics Corp.. It received FDA 510(k) clearance on 1995-12-28 under 510(k) number K943106. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the ADULT VENTILATOR?

ADULT VENTILATOR is a medical device that received FDA 510(k) clearance on 1995-12-28. The listed applicant is Infrasonics Corp.. The 510(k) number is K943106.

When did ADULT VENTILATOR receive FDA 510(k) clearance?

ADULT VENTILATOR received FDA 510(k) clearance on 1995-12-28, under 510(k) number K943106.

Who is the listed applicant for ADULT VENTILATOR?

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

What is the FDA product code for ADULT VENTILATOR?

The FDA product code for ADULT VENTILATOR 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 Infrasonics Corp. 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.

K952878OXY/STAR LOW FLOW BLENDERK934753STAR BREATHING CIRCUITSK922654VENTILATOR ADULT STAR MODIFICATIONK923704INFANT STAR SERIES 500K922477MODEL 105 VENTILATOR, MODIFICATIONK920954AIR STAR

View all 20 devices →

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

View on FDA Database →

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

↑