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FDA 510(k)

COBE AEPS

K-Number: K842054 · 1984-08-02

ApplicantCobe Laboratories, Inc.
Decision Date1984-08-02
Product CodeKRL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE AEPS 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 1984-08-02 under 510(k) number K842054. The device is classified under product code KRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE AEPS?

COBE AEPS is a medical device that received FDA 510(k) clearance on 1984-08-02. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K842054.

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

COBE AEPS received FDA 510(k) clearance on 1984-08-02, under 510(k) number K842054.

Who is the listed applicant for COBE AEPS?

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 AEPS?

The FDA product code for COBE AEPS is KRL.

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Related Devices (Code: KRL)

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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