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)

UFR DIGITAL RETROFIT

K-Number: K875312 · 1988-02-19

ApplicantYankee Intl. Medical Research & Mfg., Ltd.
Decision Date1988-02-19
Product CodeFJB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UFR DIGITAL RETROFIT is the device name listed in this FDA 510(k) record. The listed applicant is Yankee Intl. Medical Research & Mfg., Ltd.. It received FDA 510(k) clearance on 1988-02-19 under 510(k) number K875312. The device is classified under product code FJB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UFR DIGITAL RETROFIT?

UFR DIGITAL RETROFIT is a medical device that received FDA 510(k) clearance on 1988-02-19. The listed applicant is Yankee Intl. Medical Research & Mfg., Ltd.. The 510(k) number is K875312.

When did UFR DIGITAL RETROFIT receive FDA 510(k) clearance?

UFR DIGITAL RETROFIT received FDA 510(k) clearance on 1988-02-19, under 510(k) number K875312.

Who is the listed applicant for UFR DIGITAL RETROFIT?

The FDA 510(k) record lists Yankee Intl. Medical Research & Mfg., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UFR DIGITAL RETROFIT?

The FDA product code for UFR DIGITAL RETROFIT is FJB.

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: FJB)

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.

K883490ACCUFLO UF CONTROL MODULE NO. 74-0100-3National Medical Care, Medical Products Div., Inc.K881062CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002Cobe Laboratories, 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.

↑