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FDA 510(k)

HEMOPHRON

K-Number: K810612 · 1981-04-29

ApplicantRenal Devices, Inc.
Decision Date1981-04-29
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMOPHRON is the device name listed in this FDA 510(k) record. The listed applicant is Renal Devices, Inc.. It received FDA 510(k) clearance on 1981-04-29 under 510(k) number K810612. The device is classified under product code FKQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOPHRON?

HEMOPHRON is a medical device that received FDA 510(k) clearance on 1981-04-29. The listed applicant is Renal Devices, Inc.. The 510(k) number is K810612.

When did HEMOPHRON receive FDA 510(k) clearance?

HEMOPHRON received FDA 510(k) clearance on 1981-04-29, under 510(k) number K810612.

Who is the listed applicant for HEMOPHRON?

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

What is the FDA product code for HEMOPHRON?

The FDA product code for HEMOPHRON is FKQ.

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 Renal Devices, 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.

K801559HOLLO FIBER DIALYZERK802075HOLLOW FIBER DIALYZER HOLDERK790696RDI-1 HOLLOW FIBER DIALYZER

Related Devices (Code: FKQ)

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.

K052764DIACAP ULTRA DIALYSIS FLUID FILTERB. Braun Medizintechnologie GmbHK893612TWO TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.K874084MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDMNational Medical Care, Medical Products Div., Inc.K873421KAWASUMI A.V. FISTULA SETKawasumi Laboratories Co., Ltd.K870889ACID FUCHSIN SOLUTIONSD.R.G. Scientific IndustriesK861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTRenal Systems, 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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