FDA Import Refusal 799-8343755-3/1/1 — Criticare Systems (Malaysia) Sdn. Bhd.

Criticare Systems (Malaysia) Sdn. Bhd. — FEI 3008727514

The FDA refused shipment 799-8343755-3/1/1 from Criticare Systems (Malaysia) Sdn. Bhd. (Malaysia) on March 16, 2015. The refused product falls under Devices — AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE). Cited charges: 2780,341

Refusal Details

Date
March 16, 2015
Country
Malaysia
Product Category
Devices
Product Code
74MKJ AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Charges
2780,341