DOPPLEX-PLB & PXB— 510(k) K810115

Substantially Equivalent

Huntleigh Technology, Inc.

FDA 510(k) clearance K810115 for DOPPLEX-PLB & PXB, Substantially Equivalent on 1981-07-16. Applicant: Huntleigh Technology, Inc.. Device class: 2.

Clearance details

Applicant: Huntleigh Technology, Inc.
Product code: Code KNG
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 1981-01-16
Decision date: 1981-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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 Huntleigh Technology, Inc.

K992733 — AKRON ATP9 TRACTION MACHINE1999-11-10
K964699 — RHEO DOPPLEX II (RD 2)1997-02-21
K924516 — OP3/VP41993-06-28
K910188 — FLOWPLUS AC330 PUMP GARMENTS1991-05-28
K900882 — MULTI DOPPLEX, MD-11990-08-22

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