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)

A1 SYSTEME 8201/2

K-Number: K841803 · 1985-02-25

ApplicantMed USA
Decision Date1985-02-25
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

A1 SYSTEME 8201/2 is the device name listed in this FDA 510(k) record. The listed applicant is Med USA. It received FDA 510(k) clearance on 1985-02-25 under 510(k) number K841803. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A1 SYSTEME 8201/2?

A1 SYSTEME 8201/2 is a medical device that received FDA 510(k) clearance on 1985-02-25. The listed applicant is Med USA. The 510(k) number is K841803.

When did A1 SYSTEME 8201/2 receive FDA 510(k) clearance?

A1 SYSTEME 8201/2 received FDA 510(k) clearance on 1985-02-25, under 510(k) number K841803.

Who is the listed applicant for A1 SYSTEME 8201/2?

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

What is the FDA product code for A1 SYSTEME 8201/2?

The FDA product code for A1 SYSTEME 8201/2 is GKL.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Med USA 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.

K896766TD-28 DISPOSABLE ELECTRODEK862047COAGULATOR (8 CHANNEL)K852492COAGULATORK850711INHALATION THERAPY NEBULIZER DEVICE

Related Devices (Code: GKL)

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.

K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULEIris DiagnosticsK071652HEMOCUE WBC SYSTEMHemocue ABK051693MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEMBayer Healthcare, LLCK050235IQ 200 URINE ANALYZER BODY FLUIDS MODULEIris International, Inc.K032677SYSMEX POCH-100ISysmex America, Inc.

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.

↑