Airistar Technologies, LLC

FDA Regulatory Profile

Airistar Technologies, LLC appears in FDA public data with 0 recalls, 1 510(k) clearance, 3 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Jul 11, 2018 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Mar 27, 2008.

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Summary

Total Recalls
0
510(k) Clearances
1
Inspections
3
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 11, 2018Waukegan, ILDevicesNo Action Indicated (NAI)3005583594
Mar 3, 2015Waukegan, ILDevicesNo Action Indicated (NAI)3005583594
Aug 30, 2011Waukegan, ILDevicesVoluntary Action Indicated (VAI)3005583594

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K072185AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000Mar 27, 2008