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FDA 510(k)

ULTRAFILTRATION MONITOR 5M9034

K-Number: K771875 · 1977-11-30

ApplicantTravenol Laboratories, S.A.
Decision Date1977-11-30
Product CodeFIL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ULTRAFILTRATION MONITOR 5M9034 is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1977-11-30 under 510(k) number K771875. The device is classified under product code FIL. It was reviewed by the GU advisory panel. Product code FIL falls under the category of Radiology, which covers imaging devices and accessories used in diagnostic radiology. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAFILTRATION MONITOR 5M9034?

ULTRAFILTRATION MONITOR 5M9034 is a medical device that received FDA 510(k) clearance on 1977-11-30. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K771875.

When did ULTRAFILTRATION MONITOR 5M9034 receive FDA 510(k) clearance?

ULTRAFILTRATION MONITOR 5M9034 received FDA 510(k) clearance on 1977-11-30, under 510(k) number K771875.

Who is the listed applicant for ULTRAFILTRATION MONITOR 5M9034?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRAFILTRATION MONITOR 5M9034?

The FDA product code for ULTRAFILTRATION MONITOR 5M9034 is FIL. This falls under the Radiology category.

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Other records listing Travenol Laboratories, S.A. 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.

K874181BAXTER BEDSIDE SYSTEMK873894CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITEK873873RESUBMITTED MICRON TRANSFUSION FILTERK873984AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)K872364HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309K872652UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

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Related Devices (Code: FIL)

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.

K011741CRIT-LINE MONITOR III TQA (CLM TQA)HemametricsK901038SPS 550-IPS (INTEGRATED PATIENT STATION)Baxter Healthcare CorpK890329FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEMFresenius USA, Inc.K790824REPGREEN ULTRAFILTRATION MONITORCyberex Corp.K781633ULTRAFILTRATION SCALEExtracorporeal Medical Specialities, Inc.K771227AK-10Gambro, 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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