Monitor, Heart Sound, Fetal, Ultrasonic

Product Code: HEK

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 HEK

3909Monitor, Heart Sound, Fetal, UltrasonicFetal Ultrasonic Monitor And Accessories.

Total Product Life Cycle (TPLC) Devices

3909Monitor, Heart Sound, Fetal, UltrasonicFetal Ultrasonic Monitor And Accessories.

Pre-market Notifications for HEK

K142769Fetal DopplerICare Newlife Technologies, Inc.
K060410ECHOHEART TRANSVAGINAL DOPPLER PROBESUMMIT DOPPLER SYSTEMS, INC.
K902190FETAL PULSE DETECTOR MODEL DOP-1ADVANTAGE MEDICAL SYSTEMS, INC.

Global Unique Device Identification Database

60888937010697Monitor, Heart Sound, Fetal, Ultrasonic
00888937002492Monitor, Heart Sound, Fetal, Ultrasonic
00888937002485Monitor, Heart Sound, Fetal, Ultrasonic
00888937002478Monitor, Heart Sound, Fetal, Ultrasonic
00888937002461Monitor, Heart Sound, Fetal, Ultrasonic
00888937002454Monitor, Heart Sound, Fetal, Ultrasonic

Maude Adverse Events

NICOLET ELITE WATERPOOF 2MHZ DOPPLER PROBENICOLET VASCULAR2002-01-31
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