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FDA 510(k)

PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION

K-Number: K001646 · 2000-10-20

ApplicantPuritan Bennett Corp.
Decision Date2000-10-20
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION 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 2000-10-20 under 510(k) number K001646. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION?

PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION is a medical device that received FDA 510(k) clearance on 2000-10-20. The listed applicant is Puritan Bennett Corp.. The 510(k) number is K001646.

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

PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION received FDA 510(k) clearance on 2000-10-20, under 510(k) number K001646.

Who is the listed applicant for PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION?

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 PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION?

The FDA product code for PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION is CBK.

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Other records listing Puritan Bennett Corp. 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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