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)

TRANDUCER PROTECTOR

K-Number: K851428 · 1985-05-21

ApplicantGalvin Industries, Inc.
Decision Date1985-05-21
Product CodeFIB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRANDUCER PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Galvin Industries, Inc.. It received FDA 510(k) clearance on 1985-05-21 under 510(k) number K851428. The device is classified under product code FIB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANDUCER PROTECTOR?

TRANDUCER PROTECTOR is a medical device that received FDA 510(k) clearance on 1985-05-21. The listed applicant is Galvin Industries, Inc.. The 510(k) number is K851428.

When did TRANDUCER PROTECTOR receive FDA 510(k) clearance?

TRANDUCER PROTECTOR received FDA 510(k) clearance on 1985-05-21, under 510(k) number K851428.

Who is the listed applicant for TRANDUCER PROTECTOR?

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

What is the FDA product code for TRANDUCER PROTECTOR?

The FDA product code for TRANDUCER PROTECTOR is FIB.

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

Related Devices (Code: FIB)

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.

K240164NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd.K072988NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1Nipro Medical CorporationK001971HEMODIALYSIS TUBING SETSOfi Biomedica S.P.A.K010264NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SETNipro Medical Corp.K001465NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SETNipro Medical Corp.K003445FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2Fresenius Medical Care North America

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.

↑