Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AMS 3000M

K-Number: K936009 · 1995-05-03

ApplicantAcutronic Medical Systems AG
Decision Date1995-05-03
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AMS 3000M 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 1995-05-03 under 510(k) number K936009. The device is classified under product code CAP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMS 3000M?

AMS 3000M is a medical device that received FDA 510(k) clearance on 1995-05-03. The listed applicant is Acutronic Medical Systems AG. The 510(k) number is K936009.

When did AMS 3000M receive FDA 510(k) clearance?

AMS 3000M received FDA 510(k) clearance on 1995-05-03, under 510(k) number K936009.

Who is the listed applicant for AMS 3000M?

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 AMS 3000M?

The FDA product code for AMS 3000M is CAP.

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 ACCESSORIESK900744AMS 3000 PORTABLE JET VENTILATORK900745VS-200S JET VENTILATORK883865EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010K863155UNIVERSAL JET VENTILATOR MODEL AMS-1000

View all 12 devices →

Related Devices (Code: CAP)

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.

K201666SINGLE USE MANOMETERFlexicare Medical Limited.K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc.K180510NS 120P-TRS Airway Pressure GaugeInstrumentation Industries, Inc.K172284NAPA LP-15 Airway Pressure MonitorDrw Medical, LLCK153733VORTRAN ManometerVortran Medical Technology 1, Inc.K122627GIO DIGITAL PRESSURE GUAGESGalemed Corp.

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.

↑