FDA Import Refusal 799-3158359-6/11/1 — Omron

Omron — FEI 3008864308

The FDA refused shipment 799-3158359-6/11/1 from Omron (Japan) on Sep 5, 2024. The refused product falls under Devices — NEONATAL ICU CONTINUOUS NON-INVASIVE BLOOD PRESSURE MONITOR (INCLUDES ALARMS). Cited charges: 118,3280,341,508 This firm has 1 other import refusal on record.

Refusal Details

Date
Sep 5, 2024
Country
Japan
Product Category
Devices
Product Code
74QYF NEONATAL ICU CONTINUOUS NON-INVASIVE BLOOD PRESSURE MONITOR (INCLUDES ALARMS)
Charges
118,3280,341,508

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.