Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K091191 |
Device Name |
GAS TRANSFILL |
Applicant |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
1740 GOLDEN MILE HWY |
MONROEVILLE,
PA
15146
|
|
Applicant Contact |
ZITA A YURKO |
Correspondent |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
1740 GOLDEN MILE HWY |
MONROEVILLE,
PA
15146
|
|
Correspondent Contact |
ZITA A YURKO |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 04/23/2009 |
Decision Date | 10/23/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|