DIGILAB MODULAR ONE-APPLANATION TONOMETER— 510(k) K863217

Name: FDA 510(k) clearance K863217
Creator: U.S. Food and Drug Administration
Published: 1986-09-24

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K863217 for DIGILAB MODULAR ONE-APPLANATION TONOMETER, Substantially Equivalent on 1986-09-24. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code HKX
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 1986-08-20
Decision date: 1986-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

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