SLEEPMINDER BREATHING FREQUENCY INDICATOR— 510(k) K103631

Name: FDA 510(k) clearance K103631
Creator: U.S. Food and Drug Administration
Published: 2011-07-21

Substantially Equivalent

Biancamed Limited

FDA 510(k) clearance K103631 for SLEEPMINDER BREATHING FREQUENCY INDICATOR, Substantially Equivalent on 2011-07-21. Applicant: Biancamed Limited. Device class: 2.

Clearance details

Applicant: Biancamed Limited
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2010-12-13
Decision date: 2011-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belfield, Dublin, IE

Download summary PDF View on FDA.gov ↗

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