FDA 510(k) Premarket Notification K040392: TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

Submission Details & Decision

Normalized public record details for 510(k) notification K040392.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K040392

Applicant / Sponsor

American I.V. Products, Inc.

Device Name

TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

Product Code

HFM

Decision Date

2004-09-14

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Obstetrics/Gynecology (OB)

Clearance Type

Traditional

Third Party Flag

Date Received

2004-02-17

Related Establishments / Registrations

AMERICAN I.V. PRODUCTS, INC. Registration: 1121996 View Registration
Philips North America LLC Registration: 1218950 View Registration
CLINICAL INNOVATIONS, LLC Registration: 1722684 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
Brady Worldwide Registration: 3003450039 View Registration
EDAN INSTRUMENTS, INC. Registration: 3003971136 View Registration
WIPRO GE HEALTHCARE PRIVATE Ltd. Registration: 3007734888 View Registration
DHL SUPPLY CHAIN (NETHERLANDS) B.V. Registration: 3009077524 View Registration
Philips North America LLC Registration: 3012528160 View Registration
ORANTECH INC. Registration: 3013783488 View Registration
Philips Medical Systems Ltda Registration: 3014541700 View Registration
Philips North America LLC Registration: 3016701404 View Registration
Philips Medizin Systeme Boeblingen GmbH Registration: 9610816 View Registration
Wipro GE Healthcare Private Ltd. Registration: 9617277 View Registration
Nicolay GMBH Registration: 9681377 View Registration

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