SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM— 510(k) K860219

Name: FDA 510(k) clearance K860219
Creator: U.S. Food and Drug Administration
Published: 1986-04-17

Substantially Equivalent

Grass-Telefactor Product Group

FDA 510(k) clearance K860219 for SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM, Substantially Equivalent on 1986-04-17. Applicant: Grass-Telefactor Product Group. Device class: 2.

Clearance details

Applicant: Grass-Telefactor Product Group
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1986-01-22
Decision date: 1986-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: W. Conshohocken, PA, US

Download summary PDF View on FDA.gov ↗

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