SOMNITOR 32K SLEEP ACTIVITY MONITOR— 510(k) K965079

Name: FDA 510(k) clearance K965079
Creator: U.S. Food and Drug Administration
Published: 1997-07-10

Substantially Equivalent

Neurim Pharmaceuticals, Ltd.

FDA 510(k) clearance K965079 for SOMNITOR 32K SLEEP ACTIVITY MONITOR, Substantially Equivalent on 1997-07-10. Applicant: Neurim Pharmaceuticals, Ltd.. Device class: 2.

Clearance details

Applicant: Neurim Pharmaceuticals, Ltd.
Product code: Code LEL
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1996-12-19
Decision date: 1997-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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