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FDA 510(k)

COBE SYSTEM 3

K-Number: K851306 · 1985-06-12

ApplicantCobe Laboratories, Inc.
Decision Date1985-06-12
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COBE SYSTEM 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 1985-06-12 under 510(k) number K851306. 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 SYSTEM 3?

COBE SYSTEM 3 is a medical device that received FDA 510(k) clearance on 1985-06-12. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K851306.

When did COBE SYSTEM 3 receive FDA 510(k) clearance?

COBE SYSTEM 3 received FDA 510(k) clearance on 1985-06-12, under 510(k) number K851306.

Who is the listed applicant for COBE SYSTEM 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 SYSTEM 3?

The FDA product code for COBE SYSTEM 3 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 THERAPEUTICK905793COBE CENTRY 2 BICART OPTION KITK905388COBE CENTRYSYSTEM 3 BICART OPTION KITK904336NEW COBE SATURATION/HEMATOCRIT MONITORK902631COBE ICU CONVERSION KIT

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Related Devices (Code: FKP)

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.

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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