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)

ENGSTROM ELIZA DUO CO2 & O2 ANALYZ

K-Number: K840645 · 1984-04-05

ApplicantGambro, Inc.
Decision Date1984-04-05
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ENGSTROM ELIZA DUO CO2 & O2 ANALYZ is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1984-04-05 under 510(k) number K840645. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENGSTROM ELIZA DUO CO2 & O2 ANALYZ?

ENGSTROM ELIZA DUO CO2 & O2 ANALYZ is a medical device that received FDA 510(k) clearance on 1984-04-05. The listed applicant is Gambro, Inc.. The 510(k) number is K840645.

When did ENGSTROM ELIZA DUO CO2 & O2 ANALYZ receive FDA 510(k) clearance?

ENGSTROM ELIZA DUO CO2 & O2 ANALYZ received FDA 510(k) clearance on 1984-04-05, under 510(k) number K840645.

Who is the listed applicant for ENGSTROM ELIZA DUO CO2 & O2 ANALYZ?

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 ENGSTROM ELIZA DUO CO2 & O2 ANALYZ?

The FDA product code for ENGSTROM ELIZA DUO CO2 & O2 ANALYZ is CCL.

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: CCL)

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.

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter LabsK251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLCK221734Maxtec MaxO2 ME+pMaxtec, LLCK213933Percent Oxygen SensorsCareox, LLCK213948OxyMinderBio-Med Devices, 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.

↑