ORBSCAN(TM) KERATOMETER— 510(k) K940647

Substantially Equivalent

Orbtek, Inc.

FDA 510(k) clearance K940647 for ORBSCAN(TM) KERATOMETER, Substantially Equivalent on 1994-07-06. Applicant: Orbtek, Inc.. Device class: 1.

Clearance details

Applicant: Orbtek, Inc.
Product code: Code HLQ
Device class: Class 1
Regulation: 21 CFR 886.1350
Advisory panel: Ophthalmic
Date received: 1994-02-15
Decision date: 1994-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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