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ES101EX

KOVEN TECHNOLOGY, INC. · Model ES101EX-2 · UDI-DI 00894912002074

KNG Prescription
1
510(k) clearances
32
Adverse events (2 deaths)
1
Recalls
30
Facilities

Description

Fetal Echosounder Doppler.

Recalls

DateFirmReason
2017-10-06CooperSurgical, Inc.The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.