Xper Information Management/Physiomonitoring 5 System And/Or Vascular 5, Patient Care Console and Central Station
FDA 510(k) K063840 · Witt Biomedical Corp
510(k) numberK063840
Submission
- Device name
- Xper Information Management/Physiomonitoring 5 System And/Or Vascular 5, Patient Care Console and Central Station
- Applicant
- Witt Biomedical Corp
Melbourne, FL, US - Received
- December 26, 2006
- Decision date
- February 6, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K101571 | Xper Information Management and Flex Cardio Physiomonitoring SystemsMWI · Traditional | 10/26/2010SE |
| K063547 | Calysto Series IV Physio-Monitoring and Information SystemMWI · Special | 12/21/2006SE |
| K040195 | Calysto Image Iv-Image and Information Management SystemLLZ · Traditional | 04/07/2004SE |
| K033030 | Calysto Series IV Patient Care Monitors and Central Station and ECG Management SystemMWI · Traditional | 02/24/2004SE |
| K010058 | Image IV Dicom Image Archival Pacs NetworkLLZ · Traditional | 03/21/2001SE |
| K973474 | Witt Biomedical Central Station Monitoring System and Witt Biomedical Advanced Patient…MHX · Traditional | 03/13/1998SE |
| K950436 | Witt Biomedical Series IVMHX · Traditional | 11/02/1995SE |
| K945582 | Witt Biomedical Image IIILLZ · Traditional | 06/19/1995SE |
| K923054 | Witt Biomedical Series Ii-EpMHX · Traditional | 02/25/1993SE |
| K880258 | Witt Biomedical VX-80DXG · Traditional | 06/16/1988SE |
Questions and answers
When was Xper Information Management/Physiomonitoring 5 System And/Or Vascular 5, Patient Care Console and Central Station cleared by the FDA?
Xper Information Management/Physiomonitoring 5 System And/Or Vascular 5, Patient Care Console and Central Station (K063840) received a 510(k) decision of Substantially Equivalent on February 6, 2007, 42 days after the submission was received.
What is the product code of K063840?
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.