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Amplivox, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
2
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K171265Otowave 302 Portable TympanometerJuly 28, 2017
K150163Otowave 202 Portable TympanometerApril 23, 2015
K081841AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETERJuly 16, 2008