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)

FRESENIUS PURISTERIL 340 (TM)

K-Number: K874573 · 1988-04-25

ApplicantSeratronics, Inc.
Decision Date1988-04-25
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESENIUS PURISTERIL 340 (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Seratronics, Inc.. It received FDA 510(k) clearance on 1988-04-25 under 510(k) number K874573. The device is classified under product code LIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESENIUS PURISTERIL 340 (TM)?

FRESENIUS PURISTERIL 340 (TM) is a medical device that received FDA 510(k) clearance on 1988-04-25. The listed applicant is Seratronics, Inc.. The 510(k) number is K874573.

When did FRESENIUS PURISTERIL 340 (TM) receive FDA 510(k) clearance?

FRESENIUS PURISTERIL 340 (TM) received FDA 510(k) clearance on 1988-04-25, under 510(k) number K874573.

Who is the listed applicant for FRESENIUS PURISTERIL 340 (TM)?

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

What is the FDA product code for FRESENIUS PURISTERIL 340 (TM)?

The FDA product code for FRESENIUS PURISTERIL 340 (TM) is LIF.

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 Seratronics, 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.

K955299DPS 4 DIALYZER PREPARATION SYSTEMK931336DRS 4 DIALYZER REPROCESSING SYSTEMK944539DRS 4 ND DIALYZER REPROCESSING SYSTEMK923529DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCESK914580DRS-4 DIALYZER REPROCESSING SYSTEMK874872FRESENIUS HEMOFLOW F3, F4, F5, F7

View all 21 devices →

Related Devices (Code: LIF)

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.

K091360CLEARFLUX DIALYZER REPROCESSING SYSTEMNovaflux TechnologiesK043126ASSIST HEADER CLEANERAlcavis International, Inc.K040660STERICHEK GLUTARALDEHYDE REAGENT STRIPSHach CompanyK033505RENACLEAN SH DIALYZER CLEANING SYSTEMMinntech Corp.K024076MAKY 21.1 DIALYZER REPROCESSING SYSTEMHdc Maquinolas, LLCK013713ARM AUTOMATIC REPROCESSING MACHINEAlcavis International Incorporated

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.

↑