Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K210384 |
Device Name |
CARESCAPE R860 |
Applicant |
Datex-Ohmeda, Inc. |
3030 Ohmeda Drive, PO Box 7550 |
Madison,
WI
53707 -7550
|
|
Applicant Contact |
Trishia Mercier |
Correspondent |
Datex-Ohmeda, Inc. |
3030 Ohmeda Drive, PO Box 7550 |
Madison,
WI
53707 -7550
|
|
Correspondent Contact |
Monica Morrison |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 02/09/2021 |
Decision Date | 11/04/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|