Device Classification Name |
monitor, physiological, patient (without arrhythmia detection or alarms)
|
510(k) Number |
K230626 |
Device Name |
Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ W |
Applicant |
GE Medical Systems Information Technologies, Inc. |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Applicant Contact |
Joel Kent |
Correspondent |
GE Medical Systems Information Technologies, Inc. |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Correspondent Contact |
Joel Kent |
Regulation Number | 870.2300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/07/2023 |
Decision Date | 08/11/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|