Sdi Diagnostics, Inc.

FDA Regulatory Profile

Sdi Diagnostics, Inc. appears in FDA public data with 0 recalls, 10 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Jan 12, 2016.

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K150515IQSense Flow Sensor MouthpieceJan 12, 2016
K092813ASTRASONIC SPIROMETER, MODEL 29-8000Jul 16, 2010
K061571ASTRA 300Jan 31, 2007
K062913ASTRAGUARD PULMONARY FUNCTION FILTERJan 26, 2007
K033939FLOSENSE II, MODEL 29-8040Jan 30, 2004
K031643SPIROTEL, MODEL 29-1020Dec 9, 2003
K013812SPIROLAB II, MODEL 29Feb 11, 2002
K011470SDI SB OFFICE, MODEL 29-Oct 12, 2001
K990962FLOSENSE, MODEL 29-8010Jan 7, 2000
K934509PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTEROct 21, 1993