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FDA 510(k)

COBE CENTRY 2 BICART OPTION KIT

K-Number: K905793 · 1991-02-12

ApplicantCobe Laboratories, Inc.
Decision Date1991-02-12
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COBE CENTRY 2 BICART OPTION 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 1991-02-12 under 510(k) number K905793. The device is classified under product code FKP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE CENTRY 2 BICART OPTION KIT?

COBE CENTRY 2 BICART OPTION KIT is a medical device that received FDA 510(k) clearance on 1991-02-12. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K905793.

When did COBE CENTRY 2 BICART OPTION KIT receive FDA 510(k) clearance?

COBE CENTRY 2 BICART OPTION KIT received FDA 510(k) clearance on 1991-02-12, under 510(k) number K905793.

Who is the listed applicant for COBE CENTRY 2 BICART OPTION 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 CENTRY 2 BICART OPTION KIT?

The FDA product code for COBE CENTRY 2 BICART OPTION KIT is FKP.

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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 THERAPEUTICK905388COBE CENTRYSYSTEM 3 BICART OPTION KITK904336NEW COBE SATURATION/HEMATOCRIT MONITORK902631COBE ICU CONVERSION KITK902437COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER

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Related Devices (Code: FKP)

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K181991NxStage Connected Health SystemNxstage Medical, Inc.K131739NXSTAGE CONNECTED HEALTH SYSTEMNxstage Medical, Inc.K130460NXSTAGE DOSING CALCULATORNxstage Medical, Inc.K040074ONEVIEW INTERFACENxstage Medical, Inc.K021060FRESENIUS ICARE MONITORING SYSTEMFresenius Medical Care North AmericaK003615STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPSEnvironmental Test Systems, Inc.

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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