MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR— 510(k) K894030

Name: FDA 510(k) clearance K894030
Creator: U.S. Food and Drug Administration
Published: 1990-01-22

Substantially Equivalent

Healthdyne, Inc.

FDA 510(k) clearance K894030 for MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR, Substantially Equivalent on 1990-01-22. Applicant: Healthdyne, Inc.. Device class: 2.

Clearance details

Applicant: Healthdyne, Inc.
Product code: Code HFM
Device class: Class 2
Regulation: 21 CFR 884.2720
Advisory panel: Obstetrics/Gynecology
Date received: 1989-06-06
Decision date: 1990-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HFM

view all

K140163 — KOALA TOCO2014-05-29
K061044 — FEATHERLITE AQUA TOCODYNAMOMETER2006-07-12
K040392 — TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING2004-09-14
K013477 — TOCO LITE, MODEL TD-012002-01-17
K994353 — SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #35652000-03-22

More clearances from Healthdyne, Inc.

view all

K950331 — PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)1995-09-21
K922106 — ALICE1994-07-06
K942357 — H-500 ALLIANCE OXYGEN CONCENTRATOR1994-05-27
K934502 — FLOW SPIROMETER1994-04-04
K924146 — OH-500 OXYGEN CONCENTRATOR1993-01-07

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