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)

DIALYSIS MACHINES DM-346 & 346-1

K-Number: K772163 · 1977-11-28

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1977-11-28
Product CodeFIJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIALYSIS MACHINES DM-346 & 346-1 is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1977-11-28 under 510(k) number K772163. The device is classified under product code FIJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIALYSIS MACHINES DM-346 & 346-1?

DIALYSIS MACHINES DM-346 & 346-1 is a medical device that received FDA 510(k) clearance on 1977-11-28. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K772163.

When did DIALYSIS MACHINES DM-346 & 346-1 receive FDA 510(k) clearance?

DIALYSIS MACHINES DM-346 & 346-1 received FDA 510(k) clearance on 1977-11-28, under 510(k) number K772163.

Who is the listed applicant for DIALYSIS MACHINES DM-346 & 346-1?

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

What is the FDA product code for DIALYSIS MACHINES DM-346 & 346-1?

The FDA product code for DIALYSIS MACHINES DM-346 & 346-1 is FIJ.

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 Extracorporeal Medical Specialities, 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.

K843955EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATORK840262HANCOCK PERICARDIAL PATCHK840532HEMOPERFUSION SYSTEM TP-400K840057EXP* 500 PARALLEL PLATE DIALYZERK840146EXP* 700 PARALLEL PLATE DIALYZERK832547ULTRAFILTRATION CONTROLLER

View all 69 devices →

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.

↑