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Import refusals
/ AEK-4358213-6/11/1
AEK-4358213-6/11/1
Zoll Medical Corporation — FEI 2112020
Recent inspections
1171958
(VAI Mon Jun 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
800735
(VAI Tue Sep 18 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
712206
(NAI Tue Jan 11 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
683406
(VAI Fri Dec 17 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
619666
(OAI Thu Oct 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time))
Compliance actions
Warning Letter (86029)
(Fri Feb 05 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
Other import refusals
MC2-8016312-2/11/1
(Wed Nov 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
799-5298553-8/11/1
(Tue Oct 26 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
MC2-6830930-9/41/1
(Tue Mar 02 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
791-2519221-6/21/1
(Thu Mar 05 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
791-2519221-6/11/1
(Thu Mar 05 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
Refusal Details
Date
April 2, 2018
Country
United States
Product Category
Devices
Product Code
74MKJ AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Charges
118,237,3280,508