OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)— 510(k) K902954

Name: FDA 510(k) clearance K902954
Creator: U.S. Food and Drug Administration
Published: 1990-08-23

Substantially Equivalent

Permobil AB

FDA 510(k) clearance K902954 for OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC), Substantially Equivalent on 1990-08-23. Applicant: Permobil AB. Device class: 2.

Clearance details

Applicant: Permobil AB
Product code: Code HFC
Device class: Class 2
Regulation: 21 CFR 884.1050
Advisory panel: Obstetrics/Gynecology
Date received: 1990-07-05
Decision date: 1990-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

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