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FDA 510(k)

NEPTUNE HYPERBARIC VENTILATOR

K-Number: K082351 · 2009-01-02

ApplicantLevel-5, Inc.
Decision Date2009-01-02
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEPTUNE HYPERBARIC VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Level-5, Inc.. It received FDA 510(k) clearance on 2009-01-02 under 510(k) number K082351. 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 NEPTUNE HYPERBARIC VENTILATOR?

NEPTUNE HYPERBARIC VENTILATOR is a medical device that received FDA 510(k) clearance on 2009-01-02. The listed applicant is Level-5, Inc.. The 510(k) number is K082351.

When did NEPTUNE HYPERBARIC VENTILATOR receive FDA 510(k) clearance?

NEPTUNE HYPERBARIC VENTILATOR received FDA 510(k) clearance on 2009-01-02, under 510(k) number K082351.

Who is the listed applicant for NEPTUNE HYPERBARIC VENTILATOR?

The FDA 510(k) record lists Level-5, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEPTUNE HYPERBARIC VENTILATOR?

The FDA product code for NEPTUNE HYPERBARIC VENTILATOR is CBK.

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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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