Device Classification Name |
Device, Positive Pressure Breathing, Intermittent
|
510(k) Number |
K124032 |
Device Name |
METANEB |
Applicant |
HILL-ROM SERVICES PTE LTD |
1 YISHUN AVE 7 |
SINGAPORE,
SG
768923
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
HILL-ROM SERVICES PTE LTD |
1 YISHUN AVE 7 |
SINGAPORE,
SG
768923
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.5905 |
Classification Product Code |
|
Date Received | 12/28/2012 |
Decision Date | 04/25/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|