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FDA 510(k)

DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES

K-Number: K923529 · 1994-08-29

ApplicantSeratronics, Inc.
Decision Date1994-08-29
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES is the device name listed in this FDA 510(k) record. The listed applicant is Seratronics, Inc.. It received FDA 510(k) clearance on 1994-08-29 under 510(k) number K923529. 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 DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES?

DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES is a medical device that received FDA 510(k) clearance on 1994-08-29. The listed applicant is Seratronics, Inc.. The 510(k) number is K923529.

When did DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES receive FDA 510(k) clearance?

DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES received FDA 510(k) clearance on 1994-08-29, under 510(k) number K923529.

Who is the listed applicant for DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES?

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 DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES?

The FDA product code for DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES 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 SYSTEMK944539DRS 4 ND DIALYZER REPROCESSING SYSTEMK914580DRS-4 DIALYZER REPROCESSING SYSTEMK874573FRESENIUS PURISTERIL 340 (TM)K874872FRESENIUS HEMOFLOW F3, F4, F5, F7

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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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