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)

OLYMPIC CFM 6000

K-Number: K031149 · 2003-05-14

ApplicantOlympic Medical Corp.
Decision Date2003-05-14
Product CodeOMA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OLYMPIC CFM 6000 is the device name listed in this FDA 510(k) record. The listed applicant is Olympic Medical Corp.. It received FDA 510(k) clearance on 2003-05-14 under 510(k) number K031149. The device is classified under product code OMA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPIC CFM 6000?

OLYMPIC CFM 6000 is a medical device that received FDA 510(k) clearance on 2003-05-14. The listed applicant is Olympic Medical Corp.. The 510(k) number is K031149.

When did OLYMPIC CFM 6000 receive FDA 510(k) clearance?

OLYMPIC CFM 6000 received FDA 510(k) clearance on 2003-05-14, under 510(k) number K031149.

Who is the listed applicant for OLYMPIC CFM 6000?

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

What is the FDA product code for OLYMPIC CFM 6000?

The FDA product code for OLYMPIC CFM 6000 is OMA.

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 Olympic Medical Corp. 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.

K081094OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500K020335OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330K001056OLYMPIC WARM-UPK983229OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEMK971601OLYMPIC BILI-BASSINETK972193OLYMPIX MINI-PASTEURMATIC (58210)

View all 37 devices →

Related Devices (Code: OMA)

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.

K192889NeoEemagine Medical Imaging Solutions GmbHK163644Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden CorporationK161027Cadwell AmpliScanCadwell Industries, Inc.K152301Background Pattern Classification [BPc(TM)]Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K131789CEREBRALOGIK- AEEGMennen Medical , Ltd.K123079OLYMPIC BRAINZ MONITORExcel-Tech Ltd. (Xltek)

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.

↑