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)

OLYMPIX MINI-PASTEURMATIC (58210)

K-Number: K972193 · 1997-09-05

ApplicantOlympic Medical Corp.
Decision Date1997-09-05
Product CodeLDS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OLYMPIX MINI-PASTEURMATIC (58210) 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 1997-09-05 under 510(k) number K972193. The device is classified under product code LDS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPIX MINI-PASTEURMATIC (58210)?

OLYMPIX MINI-PASTEURMATIC (58210) is a medical device that received FDA 510(k) clearance on 1997-09-05. The listed applicant is Olympic Medical Corp.. The 510(k) number is K972193.

When did OLYMPIX MINI-PASTEURMATIC (58210) receive FDA 510(k) clearance?

OLYMPIX MINI-PASTEURMATIC (58210) received FDA 510(k) clearance on 1997-09-05, under 510(k) number K972193.

Who is the listed applicant for OLYMPIX MINI-PASTEURMATIC (58210)?

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 OLYMPIX MINI-PASTEURMATIC (58210)?

The FDA product code for OLYMPIX MINI-PASTEURMATIC (58210) is LDS.

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 3500K031149OLYMPIC CFM 6000K020335OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330K001056OLYMPIC WARM-UPK983229OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEMK971601OLYMPIC BILI-BASSINET

View all 37 devices →

Related Devices (Code: LDS)

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.

K183444Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level DisinfectorCenorin, LLCK031799MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881Miele, Inc.K983068RELIANCE FAMILY OF WASHER-DISINFECTORSSTERIS CorporationK950518MIELE G 7781 DENTAL THERMAL DISINFECTORMiele ProfessionalK950566DECOMAT 4656Getinge Disinfection, Inc.K953645OLYMPIC PASTEURMATIC SYSTEMOlympic Medical 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.

↑