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Remview Sleep Recorder Model 320

FDA 510(k)

Class II (US FDA 510(k))

510(k) K003499

by Respironics, Inc.

Identifiers

510(k) Number
K003499 FDA 510(k)
FDA Product Code
LEL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5050 FDA 510(k)
Regulation Number
882.5050 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Remview Sleep Recorder Model 320 is a portable device classified under Sleep Assessment, designed for recording and monitoring physiological parameters during sleep studies. It captures data such as airflow, respiratory effort, and oxygen saturation to aid in diagnosing sleep-related disorders, including obstructive sleep apnea.

This device is intended for single-use or reusable clinical settings, supplied sterile or non-sterile as specified by the manufacturer. It operates under FDA 510(k) clearance (K003499) and falls under Class II regulatory classification (882.5050). The device is intended for use in neurology-related sleep assessments and is distributed by Respironics, Inc., based in Murrysville, Pennsylvania.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: REMVIEW SLEEP RECORDER, MODEL 320 (K003499) - FDA 510 (k), REMVIEW SLEEP RECORDER, MODEL 320 - Innolitics, PDF K003499 - Remview Sleep Recorder, Model 320, Remview Sleep Recorder, Model 320 510 (k) FDA Premarket Notification ..., Medical Device Recall Information - Philips Respironics Sleep and ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Respironics, Inc.

Sources (1)

  • FDA 510(k) K003499 24 fields · synced Sep 19, 2026