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FDA 510(k)

MODIFICATION OF VENTURI VENTILATOR

K-Number: K990429 · 1999-02-24

ApplicantCardiopulmonary Corp.
Decision Date1999-02-24
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

MODIFICATION OF VENTURI VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Cardiopulmonary Corp.. It received FDA 510(k) clearance on 1999-02-24 under 510(k) number K990429. 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 MODIFICATION OF VENTURI VENTILATOR?

MODIFICATION OF VENTURI VENTILATOR is a medical device that received FDA 510(k) clearance on 1999-02-24. The listed applicant is Cardiopulmonary Corp.. The 510(k) number is K990429.

When did MODIFICATION OF VENTURI VENTILATOR receive FDA 510(k) clearance?

MODIFICATION OF VENTURI VENTILATOR received FDA 510(k) clearance on 1999-02-24, under 510(k) number K990429.

Who is the listed applicant for MODIFICATION OF VENTURI VENTILATOR?

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

What is the FDA product code for MODIFICATION OF VENTURI VENTILATOR?

The FDA product code for MODIFICATION OF VENTURI VENTILATOR is CBK.

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Other records listing Cardiopulmonary 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.

K130208BERNOULLI ENTERPRISE SOFTWAREK091461BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUEK061932BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWAREK051283MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWAREK020018MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWAREK011861BERNOULLI VENTILATOR MANAGEMENT SYSTEM

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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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