OXIMETRIX 4 COMPUTER SYSTEM— 510(k) K961661

Name: FDA 510(k) clearance K961661
Creator: U.S. Food and Drug Administration
Published: 1997-03-04

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K961661 for OXIMETRIX 4 COMPUTER SYSTEM, Substantially Equivalent on 1997-03-04. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1996-04-30
Decision date: 1997-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, 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.