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FDA 510(k)

HEATED JET HUMIDIFIER MODEL AMS-1020

K-Number: K863154 · 1987-01-12

ApplicantAcutronic Medical Systems AG
Decision Date1987-01-12
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEATED JET HUMIDIFIER MODEL AMS-1020 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 1987-01-12 under 510(k) number K863154. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEATED JET HUMIDIFIER MODEL AMS-1020?

HEATED JET HUMIDIFIER MODEL AMS-1020 is a medical device that received FDA 510(k) clearance on 1987-01-12. The listed applicant is Acutronic Medical Systems AG. The 510(k) number is K863154.

When did HEATED JET HUMIDIFIER MODEL AMS-1020 receive FDA 510(k) clearance?

HEATED JET HUMIDIFIER MODEL AMS-1020 received FDA 510(k) clearance on 1987-01-12, under 510(k) number K863154.

Who is the listed applicant for HEATED JET HUMIDIFIER MODEL AMS-1020?

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 HEATED JET HUMIDIFIER MODEL AMS-1020?

The FDA product code for HEATED JET HUMIDIFIER MODEL AMS-1020 is BTT.

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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 3000MK900745VS-200S JET VENTILATORK900744AMS 3000 PORTABLE JET VENTILATORK883865EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010

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Related Devices (Code: BTT)

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.

K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare LimitedK254078HVT 2.0Vapotherm, Inc.K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallMedline Industries, LP

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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