LIFEDOP DOPPLER— 510(k) K024197

Substantially Equivalent

Summit Doppler Systems, Inc.

FDA 510(k) clearance K024197 for LIFEDOP DOPPLER, Substantially Equivalent on 2003-01-03. Applicant: Summit Doppler Systems, Inc.. Device class: 2.

Clearance details

Applicant: Summit Doppler Systems, Inc.
Product code: Code KNG
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2002-12-20
Decision date: 2003-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arvada, CO, 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 Summit Doppler Systems, Inc.

K103693 — VANTAGE ABI2011-02-15
K101816 — STN PROBE2010-08-19
K093393 — LIFEDOP MODEL 300ABI2009-12-24
K090499 — LIFEDOP MODEL, L350R2009-03-31
K063600 — VISTA AVS2006-12-19

Recalls naming K024197

K-number listed on FDA's recall record

Z-1131-2018 — Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability.Class II·Terminated·CooperSurgical, Inc.·20171006

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K024197.

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