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 PASTEURMATIC, MODELS 3000 AND 3500

K-Number: K081094 · 2008-06-20

ApplicantOlympic Medical Corp.
Decision Date2008-06-20
Product CodeMEC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 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 2008-06-20 under 510(k) number K081094. The device is classified under product code MEC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500?

OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 is a medical device that received FDA 510(k) clearance on 2008-06-20. The listed applicant is Olympic Medical Corp.. The 510(k) number is K081094.

When did OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 receive FDA 510(k) clearance?

OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 received FDA 510(k) clearance on 2008-06-20, under 510(k) number K081094.

Who is the listed applicant for OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500?

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 PASTEURMATIC, MODELS 3000 AND 3500?

The FDA product code for OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 is MEC.

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.

K031149OLYMPIC CFM 6000K020335OLYMPIC 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: MEC)

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.

K911120DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21Hamo USA, 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.

↑