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)

1URO-LOG HOME DIAGNOSTIC PACK

K-Number: K844338 · 1985-02-25

ApplicantEpcom Medical Systems, Inc.
Decision Date1985-02-25
Product CodeFFG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

1URO-LOG HOME DIAGNOSTIC PACK is the device name listed in this FDA 510(k) record. The listed applicant is Epcom Medical Systems, Inc.. It received FDA 510(k) clearance on 1985-02-25 under 510(k) number K844338. The device is classified under product code FFG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1URO-LOG HOME DIAGNOSTIC PACK?

1URO-LOG HOME DIAGNOSTIC PACK is a medical device that received FDA 510(k) clearance on 1985-02-25. The listed applicant is Epcom Medical Systems, Inc.. The 510(k) number is K844338.

When did 1URO-LOG HOME DIAGNOSTIC PACK receive FDA 510(k) clearance?

1URO-LOG HOME DIAGNOSTIC PACK received FDA 510(k) clearance on 1985-02-25, under 510(k) number K844338.

Who is the listed applicant for 1URO-LOG HOME DIAGNOSTIC PACK?

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

What is the FDA product code for 1URO-LOG HOME DIAGNOSTIC PACK?

The FDA product code for 1URO-LOG HOME DIAGNOSTIC PACK is FFG.

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 Epcom Medical Systems, 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.

K910518GLOVE-N-GEL AMNIOTOMY KITK905812INTRAUTERINE CATHETER SETK881414CERVICATHK871079FETALFLEX FETAL ELECTRODEK844503UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACKK841805OBSTETRICAL DOPPLER

View all 13 devices →

Related Devices (Code: FFG)

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.

K893827PEAK FLOW RATE METERLaytech Medical Co.K883274SURGITEK (R) UROFLOW SYSTEMMedical Engineering Corp.K850169ERIS URO-DIAGNOSTIC SYSTEMEris Medical TechnologyK843441URINARY DRAINAGE CONTAINER 2012-WITHVital Metrics, Inc.K843442URINARY DRAINAGE CONTAINER 2013 WITHVital Metrics, Inc.K844030ACCUMETER ELECTRONIC URINEMETER SYSTEMTravenol Laboratories, S.A.

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.

↑