AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)— 510(k) K120462

Name: FDA 510(k) clearance K120462
Creator: U.S. Food and Drug Administration
Published: 2012-09-20

Substantially Equivalent

Inovise Medical, Inc.

FDA 510(k) clearance K120462 for AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION), Substantially Equivalent on 2012-09-20. Applicant: Inovise Medical, Inc.. Device class: 2.

Clearance details

Applicant: Inovise Medical, Inc.
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2012-02-15
Decision date: 2012-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaverton, OR, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MLO

view all

K261580 — ZBPro Diagnostic (Version 2.0)2026-09-11
K241890 — Philips Holter Analysis System2025-03-21
K240794 — Frontier X Plus2024-11-08
K200833 — RX-1 Rhythm Express Remote Cardiac Monitoring System2020-09-02
K193177 — CER-S2020-08-26

More clearances from Inovise Medical, Inc.

view all

K151433 — AUDICOR CA300/CC100 Analyzer with SDB2016-03-18
K131883 — AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)2014-04-11
K130660 — AUDICOR CPAM WITH SDB (SINGLE SENSOR)2013-10-11
K110569 — AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)2011-10-24
K103516 — AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.02011-02-04

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