COBE ACCESSORY INTERFACE MODULE (AIM)— 510(k) K861860

Name: FDA 510(k) clearance K861860
Creator: U.S. Food and Drug Administration
Published: 1986-07-18

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K861860 for COBE ACCESSORY INTERFACE MODULE (AIM), Substantially Equivalent on 1986-07-18. 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: 1986-05-14
Decision date: 1986-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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