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FDA 510(k)

MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES

K-Number: K012691 · 2002-12-20

ApplicantAcutronic Medical Systems AG
Decision Date2002-12-20
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES 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 2002-12-20 under 510(k) number K012691. 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 MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES?

MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2002-12-20. The listed applicant is Acutronic Medical Systems AG. The 510(k) number is K012691.

When did MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES receive FDA 510(k) clearance?

MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES received FDA 510(k) clearance on 2002-12-20, under 510(k) number K012691.

Who is the listed applicant for MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES?

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 MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES?

The FDA product code for MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES 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.

K012693MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIESK936009AMS 3000MK900744AMS 3000 PORTABLE JET VENTILATORK900745VS-200S 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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