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FDA 510(k)

HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL

K-Number: K904967 · 1991-01-28

ApplicantGambro-Hosp-Cobe, Inc.
Decision Date1991-01-28
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL is the device name listed in this FDA 510(k) record. The listed applicant is Gambro-Hosp-Cobe, Inc.. It received FDA 510(k) clearance on 1991-01-28 under 510(k) number K904967. 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 HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL?

HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL is a medical device that received FDA 510(k) clearance on 1991-01-28. The listed applicant is Gambro-Hosp-Cobe, Inc.. The 510(k) number is K904967.

When did HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL receive FDA 510(k) clearance?

HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL received FDA 510(k) clearance on 1991-01-28, under 510(k) number K904967.

Who is the listed applicant for HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL?

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

What is the FDA product code for HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL?

The FDA product code for HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL is FKP.

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Related Devices (Code: FKP)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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