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FDA 510(k)

EXTRASENSR ULTRAFILTRATION MONITOR

K-Number: K811972 · 1981-11-16

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1981-11-16
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXTRASENSR ULTRAFILTRATION MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1981-11-16 under 510(k) number K811972. The device is classified under product code FKP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTRASENSR ULTRAFILTRATION MONITOR?

EXTRASENSR ULTRAFILTRATION MONITOR is a medical device that received FDA 510(k) clearance on 1981-11-16. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K811972.

When did EXTRASENSR ULTRAFILTRATION MONITOR receive FDA 510(k) clearance?

EXTRASENSR ULTRAFILTRATION MONITOR received FDA 510(k) clearance on 1981-11-16, under 510(k) number K811972.

Who is the listed applicant for EXTRASENSR ULTRAFILTRATION MONITOR?

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

What is the FDA product code for EXTRASENSR ULTRAFILTRATION MONITOR?

The FDA product code for EXTRASENSR ULTRAFILTRATION MONITOR is FKP.

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Other records listing Extracorporeal Medical Specialities, 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.

K843955EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATORK840262HANCOCK PERICARDIAL PATCHK840532HEMOPERFUSION SYSTEM TP-400K840057EXP* 500 PARALLEL PLATE DIALYZERK840146EXP* 700 PARALLEL PLATE DIALYZERK832547ULTRAFILTRATION CONTROLLER

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Related Devices (Code: FKP)

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.

K181991NxStage Connected Health SystemNxstage Medical, Inc.K131739NXSTAGE CONNECTED HEALTH SYSTEMNxstage Medical, Inc.K130460NXSTAGE DOSING CALCULATORNxstage Medical, Inc.K040074ONEVIEW INTERFACENxstage Medical, Inc.K021060FRESENIUS ICARE MONITORING SYSTEMFresenius Medical Care North AmericaK003615STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPSEnvironmental Test 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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