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FDA 510(k)

RMI HEMOCONCENTRATOR PREFERENCE PACK

K-Number: K970739 · 1997-07-08

ApplicantResearch Medical, Inc.
Decision Date1997-07-08
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RMI HEMOCONCENTRATOR PREFERENCE PACK 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 1997-07-08 under 510(k) number K970739. 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 PREFERENCE PACK?

RMI HEMOCONCENTRATOR PREFERENCE PACK is a medical device that received FDA 510(k) clearance on 1997-07-08. The listed applicant is Research Medical, Inc.. The 510(k) number is K970739.

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

RMI HEMOCONCENTRATOR PREFERENCE PACK received FDA 510(k) clearance on 1997-07-08, under 510(k) number K970739.

Who is the listed applicant for RMI HEMOCONCENTRATOR PREFERENCE PACK?

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 PREFERENCE PACK?

The FDA product code for RMI HEMOCONCENTRATOR PREFERENCE PACK 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.

K964833RMI DUAL FLUID IRRIGATING SYRINGEK961927RMI HEMOCONCENTRACTOR TUBING SETK960098RMI INTERNAL MAMMARY ARTERY CANNULAK951344RMI HEMOCONCENTRATORK922083RMI 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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