ORION PLUS/MODIFICATION— 510(k) K904840

Substantially Equivalent

Mayer Laboratories

FDA 510(k) clearance K904840 for ORION PLUS/MODIFICATION, Substantially Equivalent on 1990-11-20. Applicant: Mayer Laboratories. Device class: 2.

Clearance details

Applicant: Mayer Laboratories
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1990-10-24
Decision date: 1990-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, CA, 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.