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FDA 510(k)

SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E

K-Number: K040221 · 2004-02-20

ApplicantMaquet Critical Care AB
Decision Date2004-02-20
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Critical Care AB. It received FDA 510(k) clearance on 2004-02-20 under 510(k) number K040221. 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 SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E?

SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E is a medical device that received FDA 510(k) clearance on 2004-02-20. The listed applicant is Maquet Critical Care AB. The 510(k) number is K040221.

When did SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E receive FDA 510(k) clearance?

SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E received FDA 510(k) clearance on 2004-02-20, under 510(k) number K040221.

Who is the listed applicant for SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E?

The FDA 510(k) record lists Maquet Critical Care AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E?

The FDA product code for SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E 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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