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FDA 510(k)

EVITAXL WITH OPTION SMARTCARE

K-Number: K051263 · 2005-07-12

ApplicantDrager Medical AG & Co. Kgaa
Decision Date2005-07-12
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EVITAXL WITH OPTION SMARTCARE is the device name listed in this FDA 510(k) record. The listed applicant is Drager Medical AG & Co. Kgaa. It received FDA 510(k) clearance on 2005-07-12 under 510(k) number K051263. 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 EVITAXL WITH OPTION SMARTCARE?

EVITAXL WITH OPTION SMARTCARE is a medical device that received FDA 510(k) clearance on 2005-07-12. The listed applicant is Drager Medical AG & Co. Kgaa. The 510(k) number is K051263.

When did EVITAXL WITH OPTION SMARTCARE receive FDA 510(k) clearance?

EVITAXL WITH OPTION SMARTCARE received FDA 510(k) clearance on 2005-07-12, under 510(k) number K051263.

Who is the listed applicant for EVITAXL WITH OPTION SMARTCARE?

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

What is the FDA product code for EVITAXL WITH OPTION SMARTCARE?

The FDA product code for EVITAXL WITH OPTION SMARTCARE is CBK.

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Other records listing Drager 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.

K093632INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CAREK072412OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500

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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