Medical Device Manufacturer · US , North Easton , MA

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

10 submissions · 10 cleared · Since 1993

Recent clearances: IQSense Flow Sensor Mouthpiece, ASTRASONIC SPIROMETER, MODEL 29-8000, ASTRA 300

View 10 510(k) Devices ↓

Total

Cleared

Denied

Sdi Diagnostics, Inc. has 10 FDA 510(k) cleared anesthesiology devices. Based in North Easton, US.

Historical record: 10 cleared submissions from 1993 to 2016.

Browse the complete list of FDA 510(k) cleared anesthesiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

Sdi Diagnostics, Inc. is one of 18344 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

10 devices

1-10 of 10

Cleared Jan 12, 2016

IQSense Flow Sensor Mouthpiece

K150515 · BZG

Anesthesiology · 316d

Cleared Jul 16, 2010

ASTRASONIC SPIROMETER, MODEL 29-8000

K092813 · BZG

Anesthesiology · 305d

Cleared Jan 31, 2007

ASTRA 300

K061571 · BZG

Anesthesiology · 239d

Cleared Jan 26, 2007

ASTRAGUARD PULMONARY FUNCTION FILTER

K062913 · BZG

Anesthesiology · 121d

Cleared Jan 30, 2004

FLOSENSE II, MODEL 29-8040

K033939 · BZG

Anesthesiology · 46d

Cleared Dec 09, 2003

SPIROTEL, MODEL 29-1020

K031643 · BZG

Anesthesiology · 196d

Cleared Feb 11, 2002

SPIROLAB II, MODEL 29

K013812 · BZG

Anesthesiology · 88d

Cleared Oct 12, 2001

SDI SB OFFICE, MODEL 29-

K011470 · BZG

Anesthesiology · 151d

Cleared Jan 07, 2000

FLOSENSE, MODEL 29-8010

K990962 · JAX

Anesthesiology · 291d

Cleared Oct 21, 1993

PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER

K934509 · CAH

General Hospital · 37d

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

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

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