DCM (Pw-Dcm)
FDA 510(k) K243513 · Pneumowave, Ltd.
510(k) numberK243513
Submission
- Device name
- DCM (Pw-Dcm)
- Applicant
- Pneumowave, Ltd.
Eurocentral, GB - Received
- November 12, 2024
- Decision date
- April 16, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LEL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252981 | EmbraceMiniLEL · Traditional | Empatica S.r.l. | 12/22/2025SE |
| K251574 | Sleep WatchLEL · Special | Ambulatory Monitoring, Inc. | 07/31/2025SE |
| K233987 | VerabandLEL · Traditional | Arbor Medical Innovations, LLC | 06/17/2024SE |
| K233618 | Oxevision Sleep DeviceLEL · Traditional | Oxehealth Limited | 04/03/2024SE |
| K231532 | ActiGraph LEAP activity monitor (ActiGraph LEAP)LEL · Special | Actigraph, LLC | 06/23/2023SE |
| K181077 | ActiGraph CentrePoint Insight WatchLEL · Special | Actigraph | 05/24/2018SE |
| K151784 | ActTrustLEL · Traditional | Condor Instruments Ltda. - Epp | 05/25/2016SE |
| K132764 | Motion Watch and Pro-DiaryLEL · Traditional | Camntech, Ltd. | 01/21/2014SE |
| K111514 | SBV2, Multicharger Model MC10V2LEL · Traditional | Sleep Performance D.B.A. Fatigue Science | 12/16/2011SE |
| K040986 | Cadwell Limb Movement ModuleLEL · Traditional | Cadwell Laboratories, Inc. | 07/01/2004SE |
Questions and answers
When was DCM (Pw-Dcm) cleared by the FDA?
DCM (Pw-Dcm) (K243513) received a 510(k) decision of Substantially Equivalent on April 16, 2025, 155 days after the submission was received.
What is the product code of K243513?
The FDA product code is LEL – Device, Sleep Assessment, a Class II (moderate risk) device regulated under 21 CFR 882.5050.