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 PRESSURE MONITOR GUARDS

K-Number: K851230 · 1985-04-09

ApplicantGambro, Inc.
Decision Date1985-04-09
Product CodeFIB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO PRESSURE MONITOR GUARDS is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1985-04-09 under 510(k) number K851230. The device is classified under product code FIB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMBRO PRESSURE MONITOR GUARDS?

GAMBRO PRESSURE MONITOR GUARDS is a medical device that received FDA 510(k) clearance on 1985-04-09. The listed applicant is Gambro, Inc.. The 510(k) number is K851230.

When did GAMBRO PRESSURE MONITOR GUARDS receive FDA 510(k) clearance?

GAMBRO PRESSURE MONITOR GUARDS received FDA 510(k) clearance on 1985-04-09, under 510(k) number K851230.

Who is the listed applicant for GAMBRO PRESSURE MONITOR GUARDS?

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 PRESSURE MONITOR GUARDS?

The FDA product code for GAMBRO PRESSURE MONITOR GUARDS is FIB.

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: FIB)

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.

K240164NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd.K072988NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1Nipro Medical CorporationK001971HEMODIALYSIS TUBING SETSOfi Biomedica S.P.A.K010264NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SETNipro Medical Corp.K001465NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SETNipro Medical Corp.K003445FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2Fresenius Medical Care North America

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.

↑