TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING— 510(k) K040392

Name: FDA 510(k) clearance K040392
Creator: U.S. Food and Drug Administration
Published: 2004-09-14

Substantially Equivalent

American I.V. Products, Inc.

FDA 510(k) clearance K040392 for TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING, Substantially Equivalent on 2004-09-14. Applicant: American I.V. Products, Inc.. Device class: 2.

Clearance details

Applicant: American I.V. Products, Inc.
Product code: Code HFM
Device class: Class 2
Regulation: 21 CFR 884.2720
Advisory panel: Obstetrics/Gynecology
Date received: 2004-02-17
Decision date: 2004-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hanover, MD, US

Download summary PDF View on FDA.gov ↗

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