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510(k) K243513

DCM (PW-DCM) by Pneumowave, Ltd. — Product Code LEL

K243513 is an FDA 510(k) premarket notification submitted by Pneumowave, Ltd. for the device "DCM (PW-DCM)". The FDA issued a decision of Substantially Equivalent on April 16, 2025. The device falls under product code LEL (Device, Sleep Assessment), a Class II device regulated under 21 CFR 882.5050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2025
Date Received
November 12, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sleep Assessment
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

Other clearances for product code LEL

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  • K233987 — VERABAND™ (June 17, 2024)
  • K233618 — Oxevision Sleep Device (April 3, 2024)
  • K231532 — ActiGraph LEAP activity monitor (ActiGraph LEAP) (June 23, 2023)
  • K181077 — ActiGraph CentrePoint Insight Watch (May 24, 2018)
  • K151784 — ActTrust (May 25, 2016)
  • K132764 — MOTION WATCH AND PRO-DIARY (January 21, 2014)
  • K111514 — SBV2, MULTICHARGER MODEL MC10V2 (December 16, 2011)
  • K040932 — EASYNET BODY POSITION MODULE (July 1, 2004)

FDA data resources