Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
FDA 510(k) K233038 · Edan Instruments, Inc.
510(k) numberK233038
Submission
- Device name
- Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
- Applicant
- Edan Instruments, Inc.
Shenzhen, CN - Received
- September 25, 2023
- Decision date
- March 8, 2024
- 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 |
|---|---|---|
| K251508 | Telemetry Monitor (iT30, iT50)MHX · Traditional | 08/06/2026SE |
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | 07/02/2026SE |
| K251591 | Holter ECG and ABP system (HolterABP)DQK · Traditional | 02/09/2026SE |
| K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)IYN · Traditional | 12/23/2025SE |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air)HGM · Traditional | 08/27/2025SE |
| K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)MHX · Traditional | 07/29/2025SE |
| K250214 | Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…IYN · Traditional | 02/20/2025SE |
| K240320 | Patient Monitor (RespArray)MHX · Traditional | 06/28/2024SE |
| K232786 | Stimulation System (PA series, PR series, S series and Q series)IPF · Traditional | 05/16/2024SE |
| K232962 | Patient Monitor (iX10, iX12, iX15)MHX · Traditional | 04/19/2024SE |
Questions and answers
When was Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s cleared by the FDA?
Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s (K233038) received a 510(k) decision of Substantially Equivalent on March 8, 2024, 165 days after the submission was received.
What is the product code of K233038?
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.