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FDA 510(k)

COBE CML3

K-Number: K880021 · 1988-04-01

ApplicantCobe Laboratories, Inc.
Decision Date1988-04-01
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE CML3 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 1988-04-01 under 510(k) number K880021. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE CML3?

COBE CML3 is a medical device that received FDA 510(k) clearance on 1988-04-01. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K880021.

When did COBE CML3 receive FDA 510(k) clearance?

COBE CML3 received FDA 510(k) clearance on 1988-04-01, under 510(k) number K880021.

Who is the listed applicant for COBE CML3?

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 CML3?

The FDA product code for COBE CML3 is DTZ.

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Related Devices (Code: DTZ)

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

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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