RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE


Device Classification Name

oximeter, reprocessed

510(k) Number K111773
Device Name RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE
Applicant
RENU MEDICAL, INC.
9800 evergreen way
everett, 
WA 
98204

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

Correspodent Contact l bruce pierson
Regulation Number 870.2700
Classification Product Code
NLF  
Date Received 06/23/2011
Decision Date 11/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No