Device Classification Name |
Incubator, Neonatal
|
510(k) Number |
K213553 |
Device Name |
Giraffe Incubator Carestation CS1 |
Applicant |
Datex Ohmeda Inc. |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Applicant Contact |
Shiwani Zalpuri |
Correspondent |
Datex Ohmeda Inc. |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Correspondent Contact |
Shiwani Zalpuri |
Regulation Number | 880.5400
|
Classification Product Code |
|
Date Received | 11/08/2021 |
Decision Date | 03/02/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|