Sdi Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K150515IQSense Flow Sensor MouthpieceJanuary 12, 2016
K092813ASTRASONIC SPIROMETER, MODEL 29-8000July 16, 2010
K061571ASTRA 300January 31, 2007
K062913ASTRAGUARD PULMONARY FUNCTION FILTERJanuary 26, 2007
K033939FLOSENSE II, MODEL 29-8040January 30, 2004
K031643SPIROTEL, MODEL 29-1020December 9, 2003
K013812SPIROLAB II, MODEL 29February 11, 2002
K011470SDI SB OFFICE, MODEL 29-October 12, 2001
K990962FLOSENSE, MODEL 29-8010January 7, 2000
K934509PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTEROctober 21, 1993