SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE— 510(k) K981665

Name: FDA 510(k) clearance K981665
Creator: U.S. Food and Drug Administration
Published: 1998-12-07

Substantially Equivalent

Bio-Medical Sciences, Inc.

FDA 510(k) clearance K981665 for SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE, Substantially Equivalent on 1998-12-07. Applicant: Bio-Medical Sciences, Inc.. Device class: 1.

Clearance details

Applicant: Bio-Medical Sciences, Inc.
Product code: Code MMQ
Device class: Class 1
Regulation: 21 CFR 886.1350
Advisory panel: Ophthalmic
Date received: 1998-05-11
Decision date: 1998-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MMQ

view all

K964702 — EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET8001997-05-20
K964891 — ORBSHOT KERATOMETER1997-03-26
K963762 — CORNEAL TOPOGRAPHER 2001996-12-23
K950077 — INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)1995-06-14

More clearances from Bio-Medical Sciences, Inc.

view all

K813202 — THERMALOG S STEAM STERILIZATION INTEGRA1981-12-31
K772358 — ETHYLENE OXIDE STERILI. INDICATOR1978-01-30

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