TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

Monitor, Uterine Contraction, External (for Use In Clinic)

AMERICAN I.V. PRODUCTS, INC.

The following data is part of a premarket notification filed by American I.v. Products, Inc. with the FDA for Transducers For Ultrasound And Tocodynamometer Fetal Monitoring.

Pre-market Notification Details

• Device ID: K040392
• 510k Number: K040392
• Device Name: TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
• Classification: Monitor, Uterine Contraction, External (for Use In Clinic)
• Applicant: AMERICAN I.V. PRODUCTS, INC. 7485 SHIPLEY AVE. Hanover, MD 21076
• Contact: Gregory Falk
• Correspondent: Gregory Falk; AMERICAN I.V. PRODUCTS, INC. 7485 SHIPLEY AVE. Hanover, MD 21076
• Product Code: HFM
• CFR Regulation Number: 884.2720 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-02-17
• Decision Date: 2004-09-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M745FM10841	K040392	000
M745FM10840	K040392	000
M745FM10839	K040392	000