Expression Information Portal
FDA 510(k) K121424 · Invivo Corporation
510(k) numberK121424
Submission
- Device name
- Expression Information Portal
- Applicant
- Invivo Corporation
Orlando, FL, US - Received
- May 14, 2012
- Decision date
- June 13, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
Other 510(k)s with product code MWI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260438 | Vital Signs Monitor (CLEO2)MWI · Traditional | Infinium Medical, Inc. | 08/14/2026SE |
| K253417 | Masimo Root Monitoring SystemMWI · Traditional | Masimo Corporation | 08/12/2026SE |
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)MWI · Traditional | Midmark Corporation | 06/12/2026SE |
| K253436 | c-med0 alphaMWI · Traditional | Cosinuss GmbH | 04/30/2026SE |
| K250135 | WAVE Clinical Platform (2.0.000)MWI · Traditional | Baxter Healthcare Corp/ Excel Medical | 01/16/2026SE |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)MWI · Traditional | Fysicon BV | 08/27/2025SE |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI · Traditional | Empatica S.r.l. | 06/06/2025SE |
| K241958 | WARD-CSS (v1.2.x)MWI · Traditional | Ward 24/7 Aps | 02/14/2025SE |
| K243146 | iCare APPMWI · Traditional | Ihealth Labs, Inc. | 02/03/2025SE |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI · Traditional | Welch Allyn, Inc. | 12/20/2024SE |
More from Welch Allyn, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K213766 | dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and…MOS · Traditional | 12/23/2021SE |
| K212227 | Philips MR Patient Care PortalMWI · Traditional | 09/30/2021SE |
| K212175 | DynaCADLLZ · Abbreviated | 08/02/2021SE |
| K193403 | UroNav SystemLLZ · Traditional | 12/27/2019SE |
| K192200 | DynaCADLLZ · Traditional | 10/09/2019SE |
| K182561 | UroNav (Version 3.0)LLZ · Traditional | 10/19/2018SE |
| K162177 | dS FootAnkle I6CH 1.5T CoilMOS · Traditional | 09/14/2016SE |
| K162001 | 1.5T and 3.0T 16 CH GE Shoulder CoilsMOS · Traditional | 08/31/2016SE |
| K152330 | Expression MR400 MRI Patient Monitoring SystemMWI · Special | 12/23/2015SE |
| K153073 | UroNav (Version 2.0)LLZ · Traditional | 11/16/2015SE |
Questions and answers
When was Expression Information Portal cleared by the FDA?
Expression Information Portal (K121424) received a 510(k) decision of Substantially Equivalent on June 13, 2012, 30 days after the submission was received.
What is the product code of K121424?
The FDA product code is MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.2300.