Device Classification Name |
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
|
510(k) Number |
K140424 |
Device Name |
RESPIRONICS REUSABLE HEATED TUBING |
Applicant |
RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY |
MONROEVILLE,
PA
15146
|
|
Applicant Contact |
ALEXANDER L FRIEDMAN |
Correspondent |
RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY |
MONROEVILLE,
PA
15146
|
|
Correspondent Contact |
ALEXANDER L FRIEDMAN |
Regulation Number | 868.5270
|
Classification Product Code |
|
Date Received | 02/19/2014 |
Decision Date | 11/14/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|