413A NEONATAL MONITOR— 510(k) K800164

Substantially Equivalent

Xerox Corp.

FDA 510(k) clearance K800164 for 413A NEONATAL MONITOR, Substantially Equivalent on 1980-04-10. Applicant: Xerox Corp.. Device class: 2.

Clearance details

Applicant: Xerox Corp.
Product code: Code FLS
Device class: Class 2
Regulation: 21 CFR 868.2377
Advisory panel: Anesthesiology
Date received: 1980-01-25
Decision date: 1980-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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