INPECTRA STO2 SPOT CHECK


Device Classification Name

oximeter, tissue saturation

510(k) Number K103613
Device Name INPECTRA STO2 SPOT CHECK
Applicant
HUTCHINSON TECHNOLOGY, INC.
40 west highland park dr. ne
hutchinson, 
MN 
55350

Applicant Contact colin m mcgraw
Correspondent
HUTCHINSON TECHNOLOGY, INC.
40 west highland park dr. ne
hutchinson, 
MN 
55350

Correspodent Contact colin m mcgraw
Regulation Number 870.2700
Classification Product Code
MUD  
Date Received 12/09/2010
Decision Date 03/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No