Transducer, Ultrasonic

Product Code: JOP

Cardiovascular Diagnostic Ultrasound Devices

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 870.2880


Radiation TypeAcoustic
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as JOP

842Transducer, UltrasonicUltrasonic Transducer.

Total Product Life Cycle (TPLC) Devices

842Transducer, UltrasonicUltrasonic Transducer.

Pre-market Notifications for JOP

K153762Smartdop XT6KOVEN TECHNOLOGY, INC.
K131860VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDINGUS VASCULAR, LLC
K131623SMARTDOP XTKOVEN TECHNOLOGY, INC.
K111416FALCONVIASONIX LTD.
K071730STUDIODOP VICORDERSKIDMORE MEDICAL, LIMITED
K010482ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1ECHOCATH, INC.
K002766NICOLET VASOGUARDNICOLET BIOMEDICAL
K990642ECHOFLOW DOPPLER BLOOD VELOCITY METERECHOCATH, INC.
K934638REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8KOVEN TECHNOLOGY, INC.
K925078SPECTRADOPBENNETT AND ASSOC., INC.
K912409MODEL HD-207 BIDIRECTIONAL VELOCITY METERKOVEN AND ASSOC., INC.
K911320EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBEAPPLIED BIOMETRICS, INC.
K910281INTRAVASCULAR IMAGING SYSTEM/MODIFIEDINTERTHERAPY, INC.
K905369UST-2266U-5 CW DOPPLER TRANSDUCERGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K905157FLOSCOPE VASCULAR LAB.ADVANCE MEDICAL DEVICE, INC.

Global Unique Device Identification Database

00816787024265TRANSDUCER, ULTRASONIC
00816787024258TRANSDUCER, ULTRASONIC
00816787024241TRANSDUCER, ULTRASONIC
00816787024234TRANSDUCER, ULTRASONIC
00816787024227TRANSDUCER, ULTRASONIC
00816787024210TRANSDUCER, ULTRASONIC
00816787024203TRANSDUCER, ULTRASONIC
00816787024197TRANSDUCER, ULTRASONIC
00816787024180TRANSDUCER, ULTRASONIC
00816787023947TRANSDUCER, ULTRASONIC
00816787023930TRANSDUCER, ULTRASONIC
00816787023923TRANSDUCER, ULTRASONIC
00816787023916TRANSDUCER, ULTRASONIC
00816787023909TRANSDUCER, ULTRASONIC
00816787023893TRANSDUCER, ULTRASONIC

Maude Adverse Events

ECHOCARDIOGRAM TRANSESOPHAGEALUNKNOWN2020-01-31
DOPPLER PROBE2017-12-28
FALCONVIASONIX2017-10-27
X72T TRANSESOPHAGEAL TRANSDUCERPHILIPS MEDICAL SYSTEMS2014-09-17
TOCO TRANSDUCERPHILIPS MEDICAL SYSTEMS, INC.2004-10-25
ULTRASONIC TRANSDUCERRICHARD WOLF GMBH2002-06-20
2002-06-20
DATALINKBECKMAN COULTER, INC.2002-03-26
ULTRASONIC TRANSDUCERRICHARD WOLF GMBH2001-08-24
ULTRASONIC TRANSDUCERRICHARD WOLF GMBH2000-02-11
2000-02-11

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