BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE


Device Classification Name

oximeter

510(k) Number K121806
Device Name BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE
Applicant
COVIDIEN
6135 gunbarrel ave.
boulder, 
CO 
80301

Applicant Contact elizabeth malo
Correspondent
COVIDIEN
6135 gunbarrel ave.
boulder, 
CO 
80301

Correspodent Contact elizabeth malo
Regulation Number 870.2700
Classification Product Code
DQA  
Subsequent Product Code
BZQ  
Date Received 06/20/2012
Decision Date 09/28/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No