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FDA 510(k)

RMI HEMOCONCENTRATOR

K-Number: K951344 · 1995-08-15

ApplicantResearch Medical, Inc.
Decision Date1995-08-15
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RMI HEMOCONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Research Medical, Inc.. It received FDA 510(k) clearance on 1995-08-15 under 510(k) number K951344. 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 RMI HEMOCONCENTRATOR?

RMI HEMOCONCENTRATOR is a medical device that received FDA 510(k) clearance on 1995-08-15. The listed applicant is Research Medical, Inc.. The 510(k) number is K951344.

When did RMI HEMOCONCENTRATOR receive FDA 510(k) clearance?

RMI HEMOCONCENTRATOR received FDA 510(k) clearance on 1995-08-15, under 510(k) number K951344.

Who is the listed applicant for RMI HEMOCONCENTRATOR?

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

What is the FDA product code for RMI HEMOCONCENTRATOR?

The FDA product code for RMI HEMOCONCENTRATOR is KDI.

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Other records listing Research Medical, 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.

K970739RMI HEMOCONCENTRATOR PREFERENCE PACKK964833RMI DUAL FLUID IRRIGATING SYRINGEK961927RMI HEMOCONCENTRACTOR TUBING SETK960098RMI INTERNAL MAMMARY ARTERY CANNULAK922083RMI SURGICCAL SITE VISUALIZATION WANDK920936RMI EXTERNAL CORONARY ARTERY OCCLUDER

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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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