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FDA 510(k)

FRESENIUS BLOOD TEMPERATURE MONITOR

K-Number: K941460 · 1996-07-03

ApplicantFresenius USA, Inc.
Decision Date1996-07-03
Product CodeMQS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESENIUS BLOOD TEMPERATURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius USA, Inc.. It received FDA 510(k) clearance on 1996-07-03 under 510(k) number K941460. The device is classified under product code MQS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESENIUS BLOOD TEMPERATURE MONITOR?

FRESENIUS BLOOD TEMPERATURE MONITOR is a medical device that received FDA 510(k) clearance on 1996-07-03. The listed applicant is Fresenius USA, Inc.. The 510(k) number is K941460.

When did FRESENIUS BLOOD TEMPERATURE MONITOR receive FDA 510(k) clearance?

FRESENIUS BLOOD TEMPERATURE MONITOR received FDA 510(k) clearance on 1996-07-03, under 510(k) number K941460.

Who is the listed applicant for FRESENIUS BLOOD TEMPERATURE MONITOR?

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

What is the FDA product code for FRESENIUS BLOOD TEMPERATURE MONITOR?

The FDA product code for FRESENIUS BLOOD TEMPERATURE MONITOR is MQS.

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Other records listing Fresenius USA, 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.

K992275FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TSK970700FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUXK974584FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TSK973378C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61K9614652008H ON LINE CLEARANCE MONITORK961706P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR

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Related Devices (Code: MQS)

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.

K232283PhySoftAMS®Physician Software Systems, LLCK180410Dosis SAMDosis, Inc.K130579PHYSOFT AMSPhysicians Software Systems, LLCK042566VASC-ALERTVasc-Alert, Inc.K022963TRANSONIC SYRINGE WARMER, MODEL SYR-1000Transonic Systems, Inc.K021571TRANSONIC FLOW-QC SET MODEL ADT1010Transonic Systems, 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.

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