FDA 510(k)

NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM

K-Number: K082724 · 2008-12-16

ApplicantNewport Medical Instruments, Inc.

Decision Date2008-12-16

Product CodeCBK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Newport Medical Instruments, Inc.. It received FDA 510(k) clearance on 2008-12-16 under 510(k) number K082724. 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 NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM?

NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM is a medical device that received FDA 510(k) clearance on 2008-12-16. The listed applicant is Newport Medical Instruments, Inc.. The 510(k) number is K082724.

When did NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM receive FDA 510(k) clearance?

NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM received FDA 510(k) clearance on 2008-12-16, under 510(k) number K082724.

Who is the listed applicant for NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM?

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

What is the FDA product code for NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM?

The FDA product code for NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Newport Medical Instruments, Inc. as applicant

K121891NEWPORT AURA VENTILATOR K111146NEWPORT HT70 VENTILATOR K101803NEWPORT E360 VENTILATOR K090888NEWPORT HT70 FAMILY OF VENTILATORS K061094NEWPORT E500 WAVE VENTILATOR K053502NEWPORT E360 VENTILATOR

View all 22 devices →

Related Devices (Code: CBK)

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa K252663Inbentus VersatileIconic Solutions by Murcia, SL K251888VPAP 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.