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FDA 510(k)

Flight 60 Ventilator

K-Number: K143035 · 2016-03-30

ApplicantFlight Medical Innovations , Ltd.
Decision Date2016-03-30
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Flight 60 Ventilator is the device name listed in this FDA 510(k) record. The listed applicant is Flight Medical Innovations , Ltd.. It received FDA 510(k) clearance on 2016-03-30 under 510(k) number K143035. 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 Flight 60 Ventilator?

Flight 60 Ventilator is a medical device that received FDA 510(k) clearance on 2016-03-30. The listed applicant is Flight Medical Innovations , Ltd.. The 510(k) number is K143035.

When did Flight 60 Ventilator receive FDA 510(k) clearance?

Flight 60 Ventilator received FDA 510(k) clearance on 2016-03-30, under 510(k) number K143035.

Who is the listed applicant for Flight 60 Ventilator?

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

What is the FDA product code for Flight 60 Ventilator?

The FDA product code for Flight 60 Ventilator is CBK.

Other records listing Flight Medical Innovations , Ltd. 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.

K223120Ventoux VC2; Ventoux VC3

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.

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