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FDA 510(k)

VS-200S JET VENTILATOR

K-Number: K900745 · 1991-04-29

ApplicantAcutronic Medical Systems AG
Decision Date1991-04-29
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VS-200S JET VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Acutronic Medical Systems AG. It received FDA 510(k) clearance on 1991-04-29 under 510(k) number K900745. 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 VS-200S JET VENTILATOR?

VS-200S JET VENTILATOR is a medical device that received FDA 510(k) clearance on 1991-04-29. The listed applicant is Acutronic Medical Systems AG. The 510(k) number is K900745.

When did VS-200S JET VENTILATOR receive FDA 510(k) clearance?

VS-200S JET VENTILATOR received FDA 510(k) clearance on 1991-04-29, under 510(k) number K900745.

Who is the listed applicant for VS-200S JET VENTILATOR?

The FDA 510(k) record lists Acutronic Medical Systems AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VS-200S JET VENTILATOR?

The FDA product code for VS-200S JET VENTILATOR is CBK.

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Other records listing Acutronic Medical Systems AG 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.

K012691MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIESK012693MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIESK936009AMS 3000MK900744AMS 3000 PORTABLE JET VENTILATORK883865EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010K863155UNIVERSAL JET VENTILATOR MODEL AMS-1000

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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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