MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325


Device Classification Name

oximeter, tissue saturation

510(k) Number K023938
Device Name MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325
Original Applicant
HUTCHINSON TECHNOLOGY, INC.
40 west highland park
hutchinson, 
MN 
55350

Original Contact thomas a dold
Regulation Number 870.2700
Classification Product Code
MUD  
Date Received 11/26/2002
Decision Date 12/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No