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FDA 510(k)

PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840

K-Number: K083693 · 2009-04-02

ApplicantCovidien, Formerly Nellcor Puritan Bennett, Inc.
Decision Date2009-04-02
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, Formerly Nellcor Puritan Bennett, Inc.. It received FDA 510(k) clearance on 2009-04-02 under 510(k) number K083693. 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 PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840?

PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 is a medical device that received FDA 510(k) clearance on 2009-04-02. The listed applicant is Covidien, Formerly Nellcor Puritan Bennett, Inc.. The 510(k) number is K083693.

When did PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 receive FDA 510(k) clearance?

PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 received FDA 510(k) clearance on 2009-04-02, under 510(k) number K083693.

Who is the listed applicant for PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840?

The FDA 510(k) record lists Covidien, Formerly Nellcor Puritan Bennett, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840?

The FDA product code for PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 is CBK.

Related Clinical Trials

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Other records listing Covidien, Formerly Nellcor Puritan Bennett, Inc. 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.

K123581NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIENK123002VITAL SYNC SYSTEMK092847840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTIONK082966PB 540 VENTILATOR

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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