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SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER - Vascular

FDA 510(k)

Class II (US FDA 510(k))

510(k) K080087

by Edan Instruments, Inc.

Identifiers

510(k) Number
K080087 FDA 510(k)
FDA Product Code
KNG FDA 510(k)
Models / Variants
Lite FDA 510(k)
Basic FDA 510(k)
Pro FDA 510(k)
Ii FDA 510(k)
Ii Pro FDA 510(k)
Vascular FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.2660 FDA 510(k)
Regulation Number
884.2660 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER - Vascular by Edan Instruments, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 6 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Edan Instruments, Inc.

Sources (1)

  • FDA 510(k) K080087 24 fields · synced Jun 18, 2026