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FDA 510(k)

ULTRAFILTRATION MONITOR UFM-10-2

K-Number: K830596 · 1983-04-27

ApplicantGambro, Inc.
Decision Date1983-04-27
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ULTRAFILTRATION MONITOR UFM-10-2 is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1983-04-27 under 510(k) number K830596. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAFILTRATION MONITOR UFM-10-2?

ULTRAFILTRATION MONITOR UFM-10-2 is a medical device that received FDA 510(k) clearance on 1983-04-27. The listed applicant is Gambro, Inc.. The 510(k) number is K830596.

When did ULTRAFILTRATION MONITOR UFM-10-2 receive FDA 510(k) clearance?

ULTRAFILTRATION MONITOR UFM-10-2 received FDA 510(k) clearance on 1983-04-27, under 510(k) number K830596.

Who is the listed applicant for ULTRAFILTRATION MONITOR UFM-10-2?

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

What is the FDA product code for ULTRAFILTRATION MONITOR UFM-10-2?

The FDA product code for ULTRAFILTRATION MONITOR UFM-10-2 is KDI.

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Other records listing Gambro, 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.

K083158EXALIS, SOFTWARE VERSION 1.15K070643PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35K032431PRISMA M60/M100 SETSK896758GAMBRO BICARBONATE MONITOR BCM 10-3K896757GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWSK902481GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER

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Related Devices (Code: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

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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