Hutchinson Technology, Inc. - FDA 510(k) Cleared Devices
Recent clearances: INPECTRA STO2 SPOT CHECK, INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650, INSPECTRA STO2 TISSUE OXYGENATION MONITOR
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hutchinson Technology, Inc. Cardiovascular ✕
8 devices
Cleared
Mar 02, 2011
INPECTRA STO2 SPOT CHECK
Cardiovascular
83d
Cleared
Apr 30, 2010
INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650
Cardiovascular
29d
Cleared
Jul 12, 2006
INSPECTRA STO2 TISSUE OXYGENATION MONITOR
Cardiovascular
33d
Cleared
Feb 08, 2006
INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325
Cardiovascular
42d
Cleared
Sep 15, 2004
SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA)
Cardiovascular
50d
Cleared
Dec 13, 2002
MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325
Cardiovascular
17d
Cleared
Jan 17, 2002
INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325
Cardiovascular
153d
Cleared
Jan 27, 1998
BIOSPECTROMETER-NB OXIMETER IIII
Cardiovascular
484d