LT-300 Video Colposcope— 510(k) K143119

Name: FDA 510(k) clearance K143119
Creator: U.S. Food and Drug Administration
Published: 2014-12-18

Substantially Equivalent

Lutech Industries, Inc.

FDA 510(k) clearance K143119 for LT-300 Video Colposcope, Substantially Equivalent on 2014-12-18. Applicant: Lutech Industries, Inc.. Device class: 2.

Clearance details

Applicant: Lutech Industries, Inc.
Product code: Code HEX
Device class: Class 2
Regulation: 21 CFR 884.1630
Advisory panel: Obstetrics/Gynecology
Date received: 2014-10-30
Decision date: 2014-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ronkonkoma, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HEX

view all

K233043 — Smart Scope® CX2024-06-14
K190187 — Gynescope System2019-05-08
K182764 — Biop Digital Colposcope2018-11-27
K181034 — Pocket Colposcope System2018-09-21
K170446 — LT-300 SD Digital Video Colposcope2017-05-21

More clearances from Lutech Industries, Inc.

view all

K160380 — LT-300 HD2016-05-13
K150691 — Datalys Multi-Parameter Patient Monitor2015-05-15

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