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FDA 510(k)

PRISMA M60/M100 SETS

K-Number: K032431 · 2003-09-15

ApplicantGambro, Inc.
Decision Date2003-09-15
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRISMA M60/M100 SETS is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 2003-09-15 under 510(k) number K032431. 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 PRISMA M60/M100 SETS?

PRISMA M60/M100 SETS is a medical device that received FDA 510(k) clearance on 2003-09-15. The listed applicant is Gambro, Inc.. The 510(k) number is K032431.

When did PRISMA M60/M100 SETS receive FDA 510(k) clearance?

PRISMA M60/M100 SETS received FDA 510(k) clearance on 2003-09-15, under 510(k) number K032431.

Who is the listed applicant for PRISMA M60/M100 SETS?

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 PRISMA M60/M100 SETS?

The FDA product code for PRISMA M60/M100 SETS is KDI.

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Other records listing Gambro, Inc. as applicant

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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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