AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)— 510(k) K131883

Name: FDA 510(k) clearance K131883
Creator: U.S. Food and Drug Administration
Published: 2014-04-11

Substantially Equivalent

Inovise Medical, Inc.

FDA 510(k) clearance K131883 for AUDICOR CPAM WITH SDB (ACCELEROMETER BASED), Substantially Equivalent on 2014-04-11. Applicant: Inovise Medical, Inc.. Device class: 2.

Clearance details

Applicant: Inovise Medical, Inc.
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2013-06-25
Decision date: 2014-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaverton, OR, US

Download summary PDF View on FDA.gov ↗

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