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FDA 510(k)

TRILOGY 100 VENTILATOR

K-Number: K083526 · 2009-03-13

ApplicantRespironics Inc., Sleep & Home Respiratory Group
Decision Date2009-03-13
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRILOGY 100 VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Respironics Inc., Sleep & Home Respiratory Group. It received FDA 510(k) clearance on 2009-03-13 under 510(k) number K083526. 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 TRILOGY 100 VENTILATOR?

TRILOGY 100 VENTILATOR is a medical device that received FDA 510(k) clearance on 2009-03-13. The listed applicant is Respironics Inc., Sleep & Home Respiratory Group. The 510(k) number is K083526.

When did TRILOGY 100 VENTILATOR receive FDA 510(k) clearance?

TRILOGY 100 VENTILATOR received FDA 510(k) clearance on 2009-03-13, under 510(k) number K083526.

Who is the listed applicant for TRILOGY 100 VENTILATOR?

The FDA 510(k) record lists Respironics Inc., Sleep & Home Respiratory Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRILOGY 100 VENTILATOR?

The FDA product code for TRILOGY 100 VENTILATOR is CBK.

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Other records listing Respironics Inc., Sleep & Home Respiratory Group as applicant

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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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