ERGO DIAGNOSTIC CARD— 510(k) K834145

Substantially Equivalent

American Ergo Systems

FDA 510(k) clearance K834145 for ERGO DIAGNOSTIC CARD, Substantially Equivalent on 1984-03-16. Applicant: American Ergo Systems. Device class: 1.

Clearance details

Applicant: American Ergo Systems
Product code: Code HOX
Device class: Class 1
Regulation: 21 CFR 886.1150
Advisory panel: Ophthalmic
Date received: 1983-12-01
Decision date: 1984-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.