AUDICOR CPAM WITH SDB (SINGLE SENSOR)— 510(k) K130660

Substantially Equivalent

Inovise Medical, Inc.

FDA 510(k) clearance K130660 for AUDICOR CPAM WITH SDB (SINGLE SENSOR), Substantially Equivalent on 2013-10-11. Applicant: Inovise Medical, Inc..

Clearance details

Applicant: Inovise Medical, Inc.
Product code: Code MLO
Advisory panel: Cardiovascular
Date received: 2013-03-12
Decision date: 2013-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaverton, OR, US

Download summary PDF View on FDA.gov ↗

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