Monitor, Blood-flow, Ultrasonic

Product Code: HEP

Obstetrics/Gynecology 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: 884.2660


Radiation TypeAcoustic
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as HEP

3914Monitor, Blood-flow, UltrasonicFetal Ultrasonic Monitor And Accessories.

Total Product Life Cycle (TPLC) Devices

3914Monitor, Blood-flow, UltrasonicFetal Ultrasonic Monitor And Accessories.

Pre-market Notifications for HEP

K101960SONOTRAX SERIES ULTRASONIC POCKET DOPPLEREDAN INSTRUMENTS, INC.
K920353ULTRACELL INSTRUMENT WIPEULTRACELL MEDICAL TECHNOLOGIES, INC.
K910462POCKET DOP 3IMEX MEDICAL SYSTEMS, INC.

Global Unique Device Identification Database

00382830028301Monitor, Blood-Flow, Ultrasonic
00382830028295Monitor, Blood-Flow, Ultrasonic
00382830028288Monitor, Blood-Flow, Ultrasonic
00382830028189Monitor, Blood-Flow, Ultrasonic
00382830028172Monitor, Blood-Flow, Ultrasonic
00382830028011Monitor, Blood-Flow, Ultrasonic
00382830028004Monitor, Blood-Flow, Ultrasonic
00815871021494Monitor, Blood-Flow, Ultrasonic
00815871020428Monitor, Blood-Flow, Ultrasonic
00815871020411Monitor, Blood-Flow, Ultrasonic
00815871020404Monitor, Blood-Flow, Ultrasonic
00815871020398Monitor, Blood-Flow, Ultrasonic
00815871020367Monitor, Blood-Flow, Ultrasonic
06944413805620Monitor, Blood-Flow, Ultrasonic
06944413805613Monitor, Blood-Flow, Ultrasonic
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