HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM— 510(k) K073269

Name: FDA 510(k) clearance K073269
Creator: U.S. Food and Drug Administration
Published: 2008-04-18

Substantially Equivalent

Hypnocore, Ltd.

FDA 510(k) clearance K073269 for HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM, Substantially Equivalent on 2008-04-18. Applicant: Hypnocore, Ltd.. Device class: 2.

Clearance details

Applicant: Hypnocore, Ltd.
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2007-11-21
Decision date: 2008-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, MA, US

Download summary PDF View on FDA.gov ↗

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