Device Classification Name |
gas-machine, anesthesia
|
510(k) Number |
K103035 |
Device Name |
SMARTPILOT VIEW MODEL MK04500 |
Applicant |
DRAEGER MEDICAL GMBH |
3135 Quarry Road |
Telford,
PA
18969
|
|
Applicant Contact |
JOYCE KILROY |
Correspondent |
DRAEGER MEDICAL GMBH |
3135 Quarry Road |
Telford,
PA
18969
|
|
Correspondent Contact |
JOYCE KILROY |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 10/13/2010 |
Decision Date | 03/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|