Somnitor 32K Sleep Activity Monitor

FDA 510(k) K965079 · Neurim Pharmaceuticals, Ltd.

Substantially Equivalent

510(k) numberK965079

Submission

Device name
Somnitor 32K Sleep Activity Monitor
Applicant
Neurim Pharmaceuticals, Ltd.
Rockville, MD, US
Received
December 19, 1996
Decision date
July 10, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 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 Somnitor 32K Sleep Activity Monitor cleared by the FDA?

Somnitor 32K Sleep Activity Monitor (K965079) received a 510(k) decision of Substantially Equivalent on July 10, 1997, 203 days after the submission was received.

What is the product code of K965079?

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