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FDA 510(k)

DRS 4 ND DIALYZER REPROCESSING SYSTEM

K-Number: K944539 · 1995-11-29

ApplicantSeratronics, Inc.
Decision Date1995-11-29
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DRS 4 ND DIALYZER REPROCESSING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Seratronics, Inc.. It received FDA 510(k) clearance on 1995-11-29 under 510(k) number K944539. 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 DRS 4 ND DIALYZER REPROCESSING SYSTEM?

DRS 4 ND DIALYZER REPROCESSING SYSTEM is a medical device that received FDA 510(k) clearance on 1995-11-29. The listed applicant is Seratronics, Inc.. The 510(k) number is K944539.

When did DRS 4 ND DIALYZER REPROCESSING SYSTEM receive FDA 510(k) clearance?

DRS 4 ND DIALYZER REPROCESSING SYSTEM received FDA 510(k) clearance on 1995-11-29, under 510(k) number K944539.

Who is the listed applicant for DRS 4 ND DIALYZER REPROCESSING SYSTEM?

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 DRS 4 ND DIALYZER REPROCESSING SYSTEM?

The FDA product code for DRS 4 ND DIALYZER REPROCESSING SYSTEM is LIF.

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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 SYSTEMK923529DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCESK914580DRS-4 DIALYZER REPROCESSING SYSTEMK874573FRESENIUS PURISTERIL 340 (TM)K874872FRESENIUS 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.

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