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Amplivox, Ltd.

FDA Regulatory Profile

Amplivox, Ltd. appears in FDA public data with 0 recalls, 3 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent 510(k) clearance was granted on July 28, 2017.

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

FDA data resources