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

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..

Clearance details

Applicant: Neurim Pharmaceuticals, Ltd.
Product code: Code LEL
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 ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.