Remview Sleep Recorder, Model 320

FDA 510(k) K003499 · Respironics, Inc.

Substantially Equivalent

510(k) numberK003499

Submission

Device name
Remview Sleep Recorder, Model 320
Applicant
Respironics, Inc.
Murrysville, PA, US
Received
November 13, 2000
Decision date
February 9, 2001
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LEL – Device, Sleep Assessment
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5050
Specialty
Neurology

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Questions and answers

When was Remview Sleep Recorder, Model 320 cleared by the FDA?

Remview Sleep Recorder, Model 320 (K003499) received a 510(k) decision of Substantially Equivalent on February 9, 2001, 88 days after the submission was received.

What is the product code of K003499?

The FDA product code is LEL – Device, Sleep Assessment, a Class II (moderate risk) device regulated under 21 CFR 882.5050.