MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION


Device Classification Name

ventilator, emergency, manual (resuscitator)

510(k) Number K991953
Device Name MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
Applicant
ENGINEERED MEDICAL SYSTEMS
2055 executive dr.
indianapolis, 
IN 
46241

Applicant Contact bonnie holly
Correspondent
ENGINEERED MEDICAL SYSTEMS
2055 executive dr.
indianapolis, 
IN 
46241

Correspodent Contact bonnie holly
Regulation Number 868.5915
Classification Product Code
BTM  
Date Received 06/01/1999
Decision Date 07/01/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No