RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25


Device Classification Name

oximeter, reprocessed

510(k) Number K072194
Device Name RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25
Applicant
RENU MEDICAL, INC.
9800 evergreen way
everett, 
WA 
98204

Applicant Contact bruce pierson
Correspondent
RENU MEDICAL, INC.
9800 evergreen way
everett, 
WA 
98204

Correspodent Contact bruce pierson
Regulation Number 870.2700
Classification Product Code
NLF  
Date Received 08/07/2007
Decision Date 11/29/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No