510(k) K251480

PV01 PVDF Effort Sensor by Neurotronics, LLC — Product Code SFK

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 29, 2025
Date Received: May 13, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Respiratory Effort Belt For Polysomnography
Device Class: Class II
Regulation Number: 882.1400
Review Panel: AN
Submission Type

To assess respiratory/breathing effort by measuring the movement of chest and abdominal walls. The belts function as accessories to sleep/polysomnography (PSG) and home sleep apnea test (HSAT) systems.

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K131415 — LIVE VIEW PANEL (LVP) (August 9, 2013)
K092699 — NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 (March 18, 2010)
K062943 — POLYSMITH SLEEP SYSTEM, MODEL NTI5498 (May 9, 2007)
K971803 — NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 (November 12, 1997)