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)

GAMBRO PERITONEAL DIALYSIS MONITOR

K-Number: K802831 · 1980-12-18

ApplicantGambro, Inc.
Decision Date1980-12-18
Product CodeKPF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO PERITONEAL DIALYSIS MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1980-12-18 under 510(k) number K802831. The device is classified under product code KPF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMBRO PERITONEAL DIALYSIS MONITOR?

GAMBRO PERITONEAL DIALYSIS MONITOR is a medical device that received FDA 510(k) clearance on 1980-12-18. The listed applicant is Gambro, Inc.. The 510(k) number is K802831.

When did GAMBRO PERITONEAL DIALYSIS MONITOR receive FDA 510(k) clearance?

GAMBRO PERITONEAL DIALYSIS MONITOR received FDA 510(k) clearance on 1980-12-18, under 510(k) number K802831.

Who is the listed applicant for GAMBRO PERITONEAL DIALYSIS MONITOR?

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

What is the FDA product code for GAMBRO PERITONEAL DIALYSIS MONITOR?

The FDA product code for GAMBRO PERITONEAL DIALYSIS MONITOR is KPF.

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 Gambro, 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.

K083158EXALIS, SOFTWARE VERSION 1.15K070643PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35K032431PRISMA M60/M100 SETSK896758GAMBRO BICARBONATE MONITOR BCM 10-3K896757GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWSK902481GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER

View all 86 devices →

Related Devices (Code: KPF)

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.

K061515RENALSOFTBaxter Healthcare CorpK990953RENAL LINKBaxter Healthcare CorpK970989CYBERRENCybernius Medical , Ltd.K955762PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAMFresenius USA, Inc.K913515TOTAL CONTAINMENT DEVICEDencoK875121AMICON EQUALINE FLUID BALANCE SYSTEMAmicon, 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.

↑