Monitor, Ultrasonic, Nonfetal

Product Code: JAF

Radiology 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: 892.1540

• Radiation Type: Acoustic
• Radition Safety: Abbreviated
• Annual Reports: No

Products Classified as JAF

5357

Monitor, Ultrasonic, Nonfetal

Nonfetal Ultrasonic Monitor.

Total Product Life Cycle (TPLC) Devices

5357

Monitor, Ultrasonic, Nonfetal

Nonfetal Ultrasonic Monitor.

FDA Consensus Standards

• Monitor, Ultrasonic, Nonfetal [37049]: 21 CFR §892.1540 🔎
• Monitor, Ultrasonic, Nonfetal [29909]: 21 CFR §892.1540 🔎

Pre-market Notifications for JAF

K141657	THD REVOLUTION	THD SPA
K110628	SIMPLEABI	NEWMAN MEDICAL
K093393	LIFEDOP MODEL 300ABI	SUMMIT DOPPLER SYSTEMS, INC.
K090009	THD SLIDE ONE	THD SPA
K081429	THD SLIDE	THD SPA
K070815	THD	G.F. S.R.L.
K063600	VISTA AVS	SUMMIT DOPPLER SYSTEMS, INC.
K060064	STETHOFLUX	ODVI
K052067	DOPPLER GUIDED PROCTOSCOPE, MODEL 500H	MULTIGON INDUSTRIES, INC.
K010521	NICOLET VERSALAB	NICOLET BIOMEDICAL
K982635	CAREDOP II	NICOLET BIOMEDICAL
K973857	FLOSTAT VASCULAR REPORT GENERATOR (VRG)	BIOMEDIX, INC.
K973644	FLOSTAT VASCULAR LAB	BIOMEDIX, INC.
K973336	IMEX STETHODOP	IMEX MEDICAL SYSTEMS, INC.
K944196	IMWXDOP IR	IMEX MEDICAL SYSTEMS, INC.

Global Unique Device Identification Database

• 00382830029896: Monitor, Ultrasonic, Nonfetal
• 00382830029889: Monitor, Ultrasonic, Nonfetal
• 00382830029872: Monitor, Ultrasonic, Nonfetal
• 00382830029865: Monitor, Ultrasonic, Nonfetal
• 00382830029858: Monitor, Ultrasonic, Nonfetal
• 00382830028325: Monitor, Ultrasonic, Nonfetal
• 00382830028318: Monitor, Ultrasonic, Nonfetal
• 00382830028233: Monitor, Ultrasonic, Nonfetal
• 00382830028226: Monitor, Ultrasonic, Nonfetal
• 00382830028219: Monitor, Ultrasonic, Nonfetal
• 00382830028202: Monitor, Ultrasonic, Nonfetal
• 00382830028196: Monitor, Ultrasonic, Nonfetal
• 00382830028165: Monitor, Ultrasonic, Nonfetal
• 00382830028158: Monitor, Ultrasonic, Nonfetal
• 00382830028080: Monitor, Ultrasonic, Nonfetal

Maude Adverse Events

THD SLIDE ONE	THD SPA	2020-03-12
ELITE AUTO SHUT-OFF 200R MAIN	NATUS NEUROLOGY INCORPORATED	2020-03-11
THD REVOLUTION	THD SPA	2020-02-10
NICOLET VERSALAB LE	NATUS NEUROLOGY, INCORPORATED	2018-01-05
THD REVOLUTION	THD SPA	2017-10-11
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-29
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-29
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-29
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-29
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-23
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-21
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-20
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-20
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-20
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-20
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-20
ELITE PROBE	NATUS NEUROLOGY, INCORPORATED	2017-06-20
THD S. P. A. - VIA INDUSTRIA	THD AMERICA, INC.	2016-08-11
THD REVOLUTION	THD AMERICA	2016-07-19