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FDA 510(k)

HEALTHDYNE IMPLUSE VENTILATOR

K-Number: K853300 · 1985-08-15

ApplicantHealthdyne, Inc.
Decision Date1985-08-15
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEALTHDYNE IMPLUSE VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne, Inc.. It received FDA 510(k) clearance on 1985-08-15 under 510(k) number K853300. 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 HEALTHDYNE IMPLUSE VENTILATOR?

HEALTHDYNE IMPLUSE VENTILATOR is a medical device that received FDA 510(k) clearance on 1985-08-15. The listed applicant is Healthdyne, Inc.. The 510(k) number is K853300.

When did HEALTHDYNE IMPLUSE VENTILATOR receive FDA 510(k) clearance?

HEALTHDYNE IMPLUSE VENTILATOR received FDA 510(k) clearance on 1985-08-15, under 510(k) number K853300.

Who is the listed applicant for HEALTHDYNE IMPLUSE VENTILATOR?

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

What is the FDA product code for HEALTHDYNE IMPLUSE VENTILATOR?

The FDA product code for HEALTHDYNE IMPLUSE VENTILATOR is CBK.

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Other records listing Healthdyne, Inc. as applicant

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K950331PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)K922106ALICEK942357H-500 ALLIANCE OXYGEN CONCENTRATORK934502FLOW SPIROMETERK924146OH-500 OXYGEN CONCENTRATORK922623NEBULIZER 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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