Device Classification Name |
Device, Positive Pressure Breathing, Intermittent
|
510(k) Number |
K200988 |
Device Name |
Maximus System |
Applicant |
Hill-Rom Services Pte Ltd |
1 Yishun Ave 7 |
Singapore,
SG
768923
|
|
Applicant Contact |
Alvin Tan |
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 | 04/15/2020 |
Decision Date | 05/26/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|