Medical Device Manufacturer · US , North Easton , MA

Sdi Diagnostics, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1993

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sdi Diagnostics, Inc. Anesthesiology ✕

9 devices

1-9 of 9

Cleared Jan 12, 2016

IQSense Flow Sensor Mouthpiece

Anesthesiology · 316d

Cleared Jul 16, 2010

ASTRASONIC SPIROMETER, MODEL 29-8000

Anesthesiology · 305d

Cleared Jan 31, 2007

Anesthesiology · 239d

Cleared Jan 26, 2007

ASTRAGUARD PULMONARY FUNCTION FILTER

Anesthesiology · 121d

Cleared Jan 30, 2004

FLOSENSE II, MODEL 29-8040

Anesthesiology · 46d

Cleared Dec 09, 2003

SPIROTEL, MODEL 29-1020

Anesthesiology · 196d

Cleared Feb 11, 2002

SPIROLAB II, MODEL 29

Anesthesiology · 88d

Cleared Oct 12, 2001

SDI SB OFFICE, MODEL 29-

Anesthesiology · 151d

Cleared Jan 07, 2000

FLOSENSE, MODEL 29-8010

Anesthesiology · 291d