Device Classification Name |
vaporizer, anesthesia, non-heated
|
510(k) Number |
K110608 |
Device Name |
SEVOFLURANE VAPORIZER ADAPTOR |
Applicant |
PIRAMAL CRITCAL CARE, INC (FORMERLY MINRAD, INC) |
50 COBHAM DRIVE |
ORCHARD PARK,
NY
14127
|
|
Applicant Contact |
JAMIE KELLER |
Correspondent |
PIRAMAL CRITCAL CARE, INC (FORMERLY MINRAD, INC) |
50 COBHAM DRIVE |
ORCHARD PARK,
NY
14127
|
|
Correspondent Contact |
JAMIE KELLER |
Regulation Number | 868.5880
|
Classification Product Code |
|
Date Received | 03/03/2011 |
Decision Date | 07/20/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|