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FDA 510(k)

UROMETER

K-Number: K833043 · 1984-02-04

ApplicantBrowne Medical, Inc.
Decision Date1984-02-04
Product CodeFFG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Browne Medical, Inc.. It received FDA 510(k) clearance on 1984-02-04 under 510(k) number K833043. 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 UROMETER?

UROMETER is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is Browne Medical, Inc.. The 510(k) number is K833043.

When did UROMETER receive FDA 510(k) clearance?

UROMETER received FDA 510(k) clearance on 1984-02-04, under 510(k) number K833043.

Who is the listed applicant for UROMETER?

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

What is the FDA product code for UROMETER?

The FDA product code for UROMETER 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 Browne Medical, 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.

K851483UROBEI STRESS INCONTINENCE MONITORK834503PROFILE URODYNAMIC MONITORING SYSK830221BEDSIDE N.P.T. 9900 - PRINTER 9800

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 TechnologyK8443381URO-LOG HOME DIAGNOSTIC PACKEpcom Medical Systems, Inc.K843441URINARY DRAINAGE CONTAINER 2012-WITHVital Metrics, Inc.K843442URINARY DRAINAGE CONTAINER 2013 WITHVital Metrics, 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.

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