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 ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)

K-Number: K952892 · 1996-02-12

ApplicantOlympus America, Inc.
Decision Date1996-02-12
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 1996-02-12 under 510(k) number K952892. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)?

OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908) is a medical device that received FDA 510(k) clearance on 1996-02-12. The listed applicant is Olympus America, Inc.. The 510(k) number is K952892.

When did OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908) receive FDA 510(k) clearance?

OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908) received FDA 510(k) clearance on 1996-02-12, under 510(k) number K952892.

Who is the listed applicant for OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)?

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

What is the FDA product code for OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)?

The FDA product code for OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908) is ITX.

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 Olympus America, 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.

K111788ENDOEYE HD IIK081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK073487OLYMPUS IGM REAGENTK073490OLYMPUS IGG REAGENTK073489OLYMPUS IGA REAGENTK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

View all 149 devices →

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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.

↑