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FDA 510(k)

HEMOSPAL KIT B22

K-Number: K911603 · 1991-08-07

ApplicantC.G.H. Medical, Inc.
Decision Date1991-08-07
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMOSPAL KIT B22 is the device name listed in this FDA 510(k) record. The listed applicant is C.G.H. Medical, Inc.. It received FDA 510(k) clearance on 1991-08-07 under 510(k) number K911603. 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 HEMOSPAL KIT B22?

HEMOSPAL KIT B22 is a medical device that received FDA 510(k) clearance on 1991-08-07. The listed applicant is C.G.H. Medical, Inc.. The 510(k) number is K911603.

When did HEMOSPAL KIT B22 receive FDA 510(k) clearance?

HEMOSPAL KIT B22 received FDA 510(k) clearance on 1991-08-07, under 510(k) number K911603.

Who is the listed applicant for HEMOSPAL KIT B22?

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

What is the FDA product code for HEMOSPAL KIT B22?

The FDA product code for HEMOSPAL KIT B22 is KDI.

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Other records listing C.G.H. 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.

K941708COBE CENTRYSYSTEM CS500 DIALYZERK933818GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTERK925522CENTRYSYSTEM 3 WITH CHARTS/BP OPTIONK920757FILTRAL HEMODIALYZERSK931720LUNDIA ALPHA 700 HEMODIALYZERK924437HEMOSPAL KIT B22 / MULTIFLOW 60 KIT

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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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