ISOL-AIDE— 510(k) K915287

Substantially Equivalent

Computronic Systems

FDA 510(k) clearance K915287 for ISOL-AIDE, Substantially Equivalent on 1992-10-16. Applicant: Computronic Systems. Device class: 2.

Clearance details

Applicant: Computronic Systems
Product code: Code CBN
Device class: Class 2
Regulation: 21 CFR 868.5430
Advisory panel: Anesthesiology
Date received: 1991-11-21
Decision date: 1992-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, 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.