ORTHOTONE— 510(k) K872111

Substantially Equivalent

Orthotone Corp.

FDA 510(k) clearance K872111 for ORTHOTONE, Substantially Equivalent on 1988-11-16. Applicant: Orthotone Corp.. Device class: 2.

Clearance details

Applicant
Orthotone Corp.
Product code
Code HLL
Device class
Class 2
Regulation
21 CFR 886.1510
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New York, NY, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code HLL

view all

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