ORBSHOT KERATOMETER— 510(k) K964891

Substantially Equivalent

Orbtek, Inc.

FDA 510(k) clearance K964891 for ORBSHOT KERATOMETER, Substantially Equivalent on 1997-03-26. Applicant: Orbtek, Inc.. Device class: 1.

Clearance details

Applicant: Orbtek, Inc.
Product code: Code MMQ
Device class: Class 1
Regulation: 21 CFR 886.1350
Advisory panel: Ophthalmic
Date received: 1996-12-06
Decision date: 1997-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MMQ

K981665 — SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE1998-12-07
K964702 — EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET8001997-05-20
K963762 — CORNEAL TOPOGRAPHER 2001996-12-23
K950077 — INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)1995-06-14

More clearances from Orbtek, Inc.

K940647 — ORBSCAN(TM) KERATOMETER1994-07-06

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