740 Select
FDA 510(k) K130411 · Cas Medical Systems, Inc.
510(k) numberK130411
Submission
- Device name
- 740 Select
- Applicant
- Cas Medical Systems, Inc.
Branford, CT, US - Received
- February 19, 2013
- Decision date
- May 29, 2013
- 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 |
|---|---|---|
| K190270 | FORE-SIGHT ELITE Tissue Oximeter ModuleMUD · Traditional | 10/21/2019SE |
| K180003 | FORE-SIGHT ELITE Module Tissue OximeterMUD · Traditional | 05/10/2018SE |
| K150620 | 740 SelectMWI · Traditional | 05/08/2015SE |
| K143675 | FORE-SIGHT Elite Absolute Tissue OximeterMUD · Traditional | 04/10/2015SE |
| K140430 | 740 SelectMWI · Traditional | 06/13/2014SE |
| K133879 | Fore-Sight Elite Absolute Tissue OximeterMUD · Traditional | 04/29/2014SE |
| K123700 | Fore-Sight Elite Absolute Tissue OximeterMUD · Traditional | 04/11/2013SE |
| K112820 | Fore-Sight Absolute Tissue OximeterMUD · Traditional | 01/26/2012SE |
| K094030 | Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000…MUD · Traditional | 12/23/2010SE |
| K091452 | Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)MUD · Traditional | 08/21/2009SE |
Questions and answers
When was 740 Select cleared by the FDA?
740 Select (K130411) received a 510(k) decision of Substantially Equivalent on May 29, 2013, 99 days after the submission was received.
What is the product code of K130411?
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.