IMT LOUPE-COLPOSCOPE— 510(k) K963593

Name: FDA 510(k) clearance K963593
Creator: U.S. Food and Drug Administration
Published: 1997-04-22

Substantially Equivalent

Inventive Medical Technology

FDA 510(k) clearance K963593 for IMT LOUPE-COLPOSCOPE, Substantially Equivalent on 1997-04-22. Applicant: Inventive Medical Technology. Device class: 2.

Clearance details

Applicant: Inventive Medical Technology
Product code: Code HEX
Device class: Class 2
Regulation: 21 CFR 884.1630
Advisory panel: Obstetrics/Gynecology
Date received: 1996-09-09
Decision date: 1997-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Trappe, MD, 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

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