Embla System Llc

FDA Regulatory Profile

Embla System Llc appears in FDA public data with 1 recall, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1532-2013, Class II) was initiated on April 24, 2013.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1532-2013Class IIembla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). April 24, 2013