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FDA 510(k)

ATLANTIS HYPERBARIC CHAMBER VENTILATOR

K-Number: K092264 · 2009-12-17

ApplicantProvidence Global Medical, Inc.
Decision Date2009-12-17
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ATLANTIS HYPERBARIC CHAMBER VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Providence Global Medical, Inc.. It received FDA 510(k) clearance on 2009-12-17 under 510(k) number K092264. 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 ATLANTIS HYPERBARIC CHAMBER VENTILATOR?

ATLANTIS HYPERBARIC CHAMBER VENTILATOR is a medical device that received FDA 510(k) clearance on 2009-12-17. The listed applicant is Providence Global Medical, Inc.. The 510(k) number is K092264.

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

ATLANTIS HYPERBARIC CHAMBER VENTILATOR received FDA 510(k) clearance on 2009-12-17, under 510(k) number K092264.

Who is the listed applicant for ATLANTIS HYPERBARIC CHAMBER VENTILATOR?

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

What is the FDA product code for ATLANTIS HYPERBARIC CHAMBER VENTILATOR?

The FDA product code for ATLANTIS HYPERBARIC CHAMBER 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.

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Other records listing Providence Global Medical, 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.

K092263ENDURAVENT-5 VENTILATOR

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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