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FDA 510(k)

NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)

K-Number: K970460 · 1998-04-30

ApplicantPuritan Bennett Corp.
Decision Date1998-04-30
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840) is the device name listed in this FDA 510(k) record. The listed applicant is Puritan Bennett Corp.. It received FDA 510(k) clearance on 1998-04-30 under 510(k) number K970460. 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 NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)?

NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840) is a medical device that received FDA 510(k) clearance on 1998-04-30. The listed applicant is Puritan Bennett Corp.. The 510(k) number is K970460.

When did NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840) receive FDA 510(k) clearance?

NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840) received FDA 510(k) clearance on 1998-04-30, under 510(k) number K970460.

Who is the listed applicant for NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)?

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

What is the FDA product code for NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)?

The FDA product code for NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840) is CBK.

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Other records listing Puritan Bennett Corp. 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.

K063650VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840K053388MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTIONK023225PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWAREK022103PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEMK001646PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTIONK002001BREEZE SLEEPGEAR WITH DREAMSEAL

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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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