RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS


Device Classification Name

heater, breathing system w/wo controller (not humidifier or nebulizer

510(k) Number K110398
Device Name RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS
Applicant
RESPIRONICS, INC.
1740 golden mile highway
monroeville, 
PA 
15146

Applicant Contact joseph e olsavsky
Correspondent
RESPIRONICS, INC.
1740 golden mile highway
monroeville, 
PA 
15146

Correspodent Contact joseph e olsavsky
Regulation Number 868.5270
Classification Product Code
BZE  
Date Received 02/11/2011
Decision Date 06/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No