COBE AEPS— 510(k) K842054

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K842054 for COBE AEPS, Substantially Equivalent on 1984-08-02. Applicant: Cobe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code KRL
Device class: Class 2
Regulation: 21 CFR 870.4205
Advisory panel: Cardiovascular
Date received: 1984-05-22
Decision date: 1984-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.