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)

OLYMPUS KC-10 MOBILE DISINFEC-STAT

K-Number: K841331 · 1984-07-19

ApplicantKeymed, Inc.
Decision Date1984-07-19
Product CodeNZA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMPUS KC-10 MOBILE DISINFEC-STAT is the device name listed in this FDA 510(k) record. The listed applicant is Keymed, Inc.. It received FDA 510(k) clearance on 1984-07-19 under 510(k) number K841331. The device is classified under product code NZA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS KC-10 MOBILE DISINFEC-STAT?

OLYMPUS KC-10 MOBILE DISINFEC-STAT is a medical device that received FDA 510(k) clearance on 1984-07-19. The listed applicant is Keymed, Inc.. The 510(k) number is K841331.

When did OLYMPUS KC-10 MOBILE DISINFEC-STAT receive FDA 510(k) clearance?

OLYMPUS KC-10 MOBILE DISINFEC-STAT received FDA 510(k) clearance on 1984-07-19, under 510(k) number K841331.

Who is the listed applicant for OLYMPUS KC-10 MOBILE DISINFEC-STAT?

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

What is the FDA product code for OLYMPUS KC-10 MOBILE DISINFEC-STAT?

The FDA product code for OLYMPUS KC-10 MOBILE DISINFEC-STAT is NZA.

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 Keymed, Inc. 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.

K100803OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1K921179OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20K881004OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECRK861821KEYMED FIBERSCOPE AUTO DISINFECTORK864801THE KEYMED HI-LIGHT 250 LIGHT SOURCEK862000KEYMED FLEXIBLE ESOPHAGEAL DILATORS

View all 29 devices →

Related Devices (Code: NZA)

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.

K232918enspire 300 Series Automated Endoscope ReprocessorSTERIS CorporationK230560enspire 300 Series Automated Endoscope Reprocessor SystemSTERIS CorporationK220361Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideSTERIS CorporationK203223Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideSterisK200989Reliance Endoscope Processing SystemSTERIS CorporationK123768RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEMSTERIS Corporation

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.

↑