FDA 510(k)

VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1

K-Number: K122560 · 2013-03-26

Decision Date2013-03-26

Product CodeCBK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1 is the device name listed in this FDA 510(k) record. The listed applicant is Pan-America Hyperbarics, Inc.. It received FDA 510(k) clearance on 2013-03-26 under 510(k) number K122560. 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 VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1?

VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1 is a medical device that received FDA 510(k) clearance on 2013-03-26. The listed applicant is Pan-America Hyperbarics, Inc.. The 510(k) number is K122560.

When did VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1 receive FDA 510(k) clearance?

VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1 received FDA 510(k) clearance on 2013-03-26, under 510(k) number K122560.

Who is the listed applicant for VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1?

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

What is the FDA product code for VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1?

The FDA product code for VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1 is CBK.

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Other records listing Pan-America Hyperbarics, Inc. as applicant

K021689PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2 K021690PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1 K021693PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1

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

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