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, JET SYSTEM

K-Number: K770331 · 1977-04-20

ApplicantJanneck Ent. of Texas
Decision Date1977-04-20
Product CodeEKP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIALYSIS, JET SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Janneck Ent. of Texas. It received FDA 510(k) clearance on 1977-04-20 under 510(k) number K770331. The device is classified under product code EKP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIALYSIS, JET SYSTEM?

DIALYSIS, JET SYSTEM is a medical device that received FDA 510(k) clearance on 1977-04-20. The listed applicant is Janneck Ent. of Texas. The 510(k) number is K770331.

When did DIALYSIS, JET SYSTEM receive FDA 510(k) clearance?

DIALYSIS, JET SYSTEM received FDA 510(k) clearance on 1977-04-20, under 510(k) number K770331.

Who is the listed applicant for DIALYSIS, JET SYSTEM?

The FDA 510(k) record lists Janneck Ent. of Texas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIALYSIS, JET SYSTEM?

The FDA product code for DIALYSIS, JET SYSTEM is EKP.

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

Related Devices (Code: EKP)

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.

K823686REAMER TYPE K ENDODONTICUnited Dental Mfg., Inc.K822620ROOT CANAL REAMERS, TYPE KUnion Broach, Div. Moyco Industries, Inc.K800291ENDEX REAMERS PULP CANAL, ENDODONTICIpco Corp.K770598ENDODONTIC INSTRUMENTS, R&R CUTWELLRansom and RandolphK770367ROOT CANAL FILES & REAMERSCemco Tool Co., 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.

↑