BTE Technologies, Inc.

FDA Regulatory Profile

BTE Technologies, Inc. appears in FDA public data with 1 recall, 0 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1986-2015, Class II) was initiated on April 9, 2015.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1986-2015Class IIPrimus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment devicApril 9, 2015