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FDA 510(k)

Puritan Bennett 980 Ventilator System

K-Number: K162738 · 2017-10-27

ApplicantCovidien
Decision Date2017-10-27
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Puritan Bennett 980 Ventilator System is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2017-10-27 under 510(k) number K162738. 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 Puritan Bennett 980 Ventilator System?

Puritan Bennett 980 Ventilator System is a medical device that received FDA 510(k) clearance on 2017-10-27. The listed applicant is Covidien. The 510(k) number is K162738.

When did Puritan Bennett 980 Ventilator System receive FDA 510(k) clearance?

Puritan Bennett 980 Ventilator System received FDA 510(k) clearance on 2017-10-27, under 510(k) number K162738.

Who is the listed applicant for Puritan Bennett 980 Ventilator System?

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

What is the FDA product code for Puritan Bennett 980 Ventilator System?

The FDA product code for Puritan Bennett 980 Ventilator System 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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