MGD-3— 510(k) K800095

Substantially Equivalent

Kt Medical, Inc.

FDA 510(k) clearance K800095 for MGD-3, Substantially Equivalent on 1980-02-11. Applicant: Kt Medical, Inc.. Device class: 2.

Clearance details

Applicant: Kt Medical, Inc.
Product code: Code KNG
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 1980-01-14
Decision date: 1980-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNG

K252669 — Fetal Doppler U8-25, U9-252026-01-08
K242846 — Doppler FHR Detector (BF-500D+, BF-560)2025-06-26
K233823 — Ultrasonic Fetal Doppler2024-06-28
K232893 — Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)2024-06-14
K220245 — Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)2022-09-28

More clearances from Kt Medical, Inc.

K800653 — SINVISION LINEAR ARRAY REAL TIME1980-07-21
K800652 — MODEL E03 ECHO-OPTHALMOSCOPE1980-05-14
K800101 — 4200 ME ECHOENCEPHALOGRAPH1980-05-02
K800092 — COMBISON COMPUTER1980-04-08
K800099 — INTRACULA II1980-02-21

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