Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Portrait VSM

K-Number: K233810 · 2024-04-25

ApplicantGe Medical Systems Information Technologies, Inc.
Decision Date2024-04-25
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Portrait VSM is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2024-04-25 under 510(k) number K233810. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Portrait VSM?

Portrait VSM is a medical device that received FDA 510(k) clearance on 2024-04-25. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K233810.

When did Portrait VSM receive FDA 510(k) clearance?

Portrait VSM received FDA 510(k) clearance on 2024-04-25, under 510(k) number K233810.

Who is the listed applicant for Portrait VSM?

The FDA 510(k) record lists Ge Medical Systems Information Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portrait VSM?

The FDA product code for Portrait VSM is MWI.

Other records listing Ge Medical Systems Information Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PK251670MAC 7 Resting ECG Analysis SystemK242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PK243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse OK231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System

View all 21 devices →

Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑