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Audicor CPAM With SDB (Accelerometer Based)

by Inovise Medical, Inc.

510(k) K131883

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK131883 Date11 Apr 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MNR
Device Class
Class II
Regulation
21 CFR Part 868.2375
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Audicor CPAM With SDB (Accelerometer Based) is classified as a Class II ventilatory effort recorder. It records cardiopulmonary signals and uses an accelerometer to detect sleep‑disordered breathing events during ambulatory monitoring.

The device was cleared through a traditional FDA 510(k) submission (K131883) on 11 April 2014 and is assigned product code MNR. It is supplied by Inovise Medical, Inc. and is intended for use in anesthesiology settings as a single‑use, sterile monitor, with storage and handling as specified by the manufacturer.

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