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FDA 510(k)

SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800

K-Number: K063404 · 2007-02-15

ApplicantMaquet Critical Care AB
Decision Date2007-02-15
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800 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 2007-02-15 under 510(k) number K063404. 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, MODELS 64, 87 AND 800?

SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800 is a medical device that received FDA 510(k) clearance on 2007-02-15. The listed applicant is Maquet Critical Care AB. The 510(k) number is K063404.

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

SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800 received FDA 510(k) clearance on 2007-02-15, under 510(k) number K063404.

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

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, MODELS 64, 87 AND 800?

The FDA product code for SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800 is CBK.

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Other records listing Maquet Critical Care AB as applicant

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K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279)K230173Servo-air Lite Ventilator SystemK201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemK182862Servo GuardK180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1

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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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