Sleep Management System

FDA 510(k) K981844 · Rmp, Inc.

Substantially Equivalent

510(k) numberK981844

Submission

Device name
Sleep Management System
Applicant
Rmp, Inc.
Washington, DC, US
Received
May 26, 1998
Decision date
August 7, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HCC – Device, Biofeedback
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5050
Specialty
Neurology

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Questions and answers

When was Sleep Management System cleared by the FDA?

Sleep Management System (K981844) received a 510(k) decision of Substantially Equivalent on August 7, 1998, 73 days after the submission was received.

What is the product code of K981844?

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