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FDA 510(k)

LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA

K-Number: K040642 · 2004-06-02

ApplicantDraeget Medical AG & Co. Kgaa
Decision Date2004-06-02
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA is the device name listed in this FDA 510(k) record. The listed applicant is Draeget Medical AG & Co. Kgaa. It received FDA 510(k) clearance on 2004-06-02 under 510(k) number K040642. 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 LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA?

LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA is a medical device that received FDA 510(k) clearance on 2004-06-02. The listed applicant is Draeget Medical AG & Co. Kgaa. The 510(k) number is K040642.

When did LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA receive FDA 510(k) clearance?

LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA received FDA 510(k) clearance on 2004-06-02, under 510(k) number K040642.

Who is the listed applicant for LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA?

The FDA 510(k) record lists Draeget Medical AG & Co. Kgaa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA?

The FDA product code for LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA is CBK.

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Other records listing Draeget Medical AG & Co. Kgaa 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.

K041956EMG - ESSENTIAL GAS MODULE, MODEL M1013A

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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