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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 2MHz CW Water Proof Probe; 2MHz Normal Probe; 3MHz CW Normal Probe; 3MHz CW Water Proof Probe;; Baby Sound A Pocket Fetal Doppler; Baby Sound B Pocket Fetal Doppler; Baby Sound C Pocket Fetal Doppler; Sonoline A Pocket Fetal Doppler; Sonoline B Pocket Fetal Doppler
Classification Name: MONITOR, ULTRASONIC, FETAL
Product Code: KNG
Device Class: 2
Regulation Number: 884.2660
Medical Specialty: Obstetrics/Gynecology
Registered Establishment Name: CONTEC MEDICAL SYSTEMS CO., LTD
Registered Establishment Number: 3006979678
Premarket Submission Number: K082480
Owner/Operator: CONTEC MEDICAL SYSTEMS CO., LTD
Owner/Operator Number: 10025156
Establishment Operations: Manufacturer
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