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FDA 510(k)

HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L

K-Number: K994198 · 2000-08-25

ApplicantToray Industries (America), Inc.
Decision Date2000-08-25
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L is the device name listed in this FDA 510(k) record. The listed applicant is Toray Industries (America), Inc.. It received FDA 510(k) clearance on 2000-08-25 under 510(k) number K994198. 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 HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L?

HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L is a medical device that received FDA 510(k) clearance on 2000-08-25. The listed applicant is Toray Industries (America), Inc.. The 510(k) number is K994198.

When did HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L receive FDA 510(k) clearance?

HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L received FDA 510(k) clearance on 2000-08-25, under 510(k) number K994198.

Who is the listed applicant for HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L?

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

What is the FDA product code for HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L?

The FDA product code for HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L is KDI.

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Other records listing Toray Industries (America), Inc. as applicant

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K042370TORAYGUIDE GUIDEWIREK030050TORAYSULFONE DIALYZER, BS-L SERIESK002512TORAYSULFONE DIALYZERK942681FILTRYZERK935471FILTRYZER(TM)K940910FILTRYZER

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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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