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FDA 510(k)

COBE HC 700 MIDI HEMOCONCENTRATOR

K-Number: K003023 · 2001-04-30

ApplicantHospal Industrie
Decision Date2001-04-30
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COBE HC 700 MIDI HEMOCONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Hospal Industrie. It received FDA 510(k) clearance on 2001-04-30 under 510(k) number K003023. 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 HC 700 MIDI HEMOCONCENTRATOR?

COBE HC 700 MIDI HEMOCONCENTRATOR is a medical device that received FDA 510(k) clearance on 2001-04-30. The listed applicant is Hospal Industrie. The 510(k) number is K003023.

When did COBE HC 700 MIDI HEMOCONCENTRATOR receive FDA 510(k) clearance?

COBE HC 700 MIDI HEMOCONCENTRATOR received FDA 510(k) clearance on 2001-04-30, under 510(k) number K003023.

Who is the listed applicant for COBE HC 700 MIDI HEMOCONCENTRATOR?

The FDA 510(k) record lists Hospal Industrie as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBE HC 700 MIDI HEMOCONCENTRATOR?

The FDA product code for COBE HC 700 MIDI HEMOCONCENTRATOR is KDI.

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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.

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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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