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510(k) K243513

Device
DCM (PW-DCM)
Applicant
Pneumowave, Ltd.
510(k) number
K243513
Product code
LEL
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-16
Date received
2024-11-12
Regulation
882.5050
Classification name
Device, Sleep Assessment
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Stuart Kelly
Address
Suites 3 And 4, Second Floor, Maxim 3 Maxim Office Park, Parklands Ave. Eurocentral GB ML1 4WQ ML1 4WQ

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K981969ULTIMA BODY POSITION SENSORBraebon Medical Corp.1998-08-20
K961817B SMART MODEL 1Koven Technology, Inc.1997-07-23
K965079SOMNITOR 32K SLEEP ACTIVITY MONITORNeurim Pharmaceuticals, Ltd.1997-07-10