FDA 510(k)

840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION

K-Number: K092847 · 2010-03-11

ApplicantCovidien, Formerly Nellcor Puritan Bennett, Inc.

Decision Date2010-03-11

Product CodeCBK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION 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 2010-03-11 under 510(k) number K092847. 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 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION?

840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION is a medical device that received FDA 510(k) clearance on 2010-03-11. The listed applicant is Covidien, Formerly Nellcor Puritan Bennett, Inc.. The 510(k) number is K092847.

When did 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION receive FDA 510(k) clearance?

840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION received FDA 510(k) clearance on 2010-03-11, under 510(k) number K092847.

Who is the listed applicant for 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION?

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 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION?

The FDA product code for 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION is CBK.

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

K123581NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN K123002VITAL SYNC SYSTEM K083693PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 K082966PB 540 VENTILATOR

Related Devices (Code: CBK)

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa K252663Inbentus VersatileIconic Solutions by Murcia, SL K251888VPAP 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.