Sensor Medical Single Use Tonometer Prism— 510(k) K152308

Name: FDA 510(k) clearance K152308
Creator: U.S. Food and Drug Administration
Published: 2015-10-13

Substantially Equivalent

Sensor Medical Technology, LLC

FDA 510(k) clearance K152308 for Sensor Medical Single Use Tonometer Prism, Substantially Equivalent on 2015-10-13. Applicant: Sensor Medical Technology, LLC. Device class: 2.

Clearance details

Applicant: Sensor Medical Technology, LLC
Product code: Code HKY
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2015-08-14
Decision date: 2015-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Valley, WA, US

Download summary PDF View on FDA.gov ↗

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