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FDA 510(k)

COBE HEMOCONCENTRATOR 1.3

K-Number: K823338 · 1983-01-07

ApplicantCobe Laboratories, Inc.
Decision Date1983-01-07
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COBE HEMOCONCENTRATOR 1.3 is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1983-01-07 under 510(k) number K823338. 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 COBE HEMOCONCENTRATOR 1.3?

COBE HEMOCONCENTRATOR 1.3 is a medical device that received FDA 510(k) clearance on 1983-01-07. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K823338.

When did COBE HEMOCONCENTRATOR 1.3 receive FDA 510(k) clearance?

COBE HEMOCONCENTRATOR 1.3 received FDA 510(k) clearance on 1983-01-07, under 510(k) number K823338.

Who is the listed applicant for COBE HEMOCONCENTRATOR 1.3?

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

What is the FDA product code for COBE HEMOCONCENTRATOR 1.3?

The FDA product code for COBE HEMOCONCENTRATOR 1.3 is KDI.

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Other records listing Cobe Laboratories, 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.

K923272COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATORK900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTICK905793COBE CENTRY 2 BICART OPTION KITK905388COBE CENTRYSYSTEM 3 BICART OPTION KITK904336NEW COBE SATURATION/HEMATOCRIT MONITORK902437COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER

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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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