Device Classification Name |
monitor, apnea, home use
|
510(k) Number |
K061256 |
Device Name |
SMARTMONITOR 2PS |
Applicant |
RESPIRONICS, INC. |
1001 MURRY RIDGE LN. |
MURRYSVILLE,
PA
15668
|
|
Applicant Contact |
ZITA A YURKO |
Correspondent |
RESPIRONICS, INC. |
1001 MURRY RIDGE LN. |
MURRYSVILLE,
PA
15668
|
|
Correspondent Contact |
ZITA A YURKO |
Regulation Number | 868.2377
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/04/2006 |
Decision Date | 08/02/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|