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FDA 510(k)

COBE ICU CONVERSION KIT

K-Number: K902631 · 1990-12-17

ApplicantCobe Laboratories, Inc.
Decision Date1990-12-17
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE ICU CONVERSION KIT 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 1990-12-17 under 510(k) number K902631. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE ICU CONVERSION KIT?

COBE ICU CONVERSION KIT is a medical device that received FDA 510(k) clearance on 1990-12-17. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K902631.

When did COBE ICU CONVERSION KIT receive FDA 510(k) clearance?

COBE ICU CONVERSION KIT received FDA 510(k) clearance on 1990-12-17, under 510(k) number K902631.

Who is the listed applicant for COBE ICU CONVERSION KIT?

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 ICU CONVERSION KIT?

The FDA product code for COBE ICU CONVERSION KIT is DTN.

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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: DTN)

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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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