Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered Breathing Detection)
FDA 510(k) K120462 · Inovise Medical, Inc.
510(k) numberK120462
Submission
- Device name
- Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered Breathing Detection)
- Applicant
- Inovise Medical, Inc.
Beaverton, OR, US - Received
- February 15, 2012
- Decision date
- September 20, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MLO – Electrocardiograph, Ambulatory, With Analysis Algorithm
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
Other 510(k)s with product code MLO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261580 | ZBPro Diagnostic (Version 2.0)MLO · Traditional | Zbeats, Inc. | 09/11/2026SE |
| K241890 | Philips Holter Analysis SystemMLO · Traditional | Philips Medizin Systeme Böblingen GmbH | 03/21/2025SE |
| K240794 | Frontier X PlusMLO · Traditional | Fourth Frontier Technologies Pvt, Ltd. | 11/08/2024SE |
| K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring SystemMLO · Traditional | VivaQuant, Inc. | 09/02/2020SE |
| K193177 | Cer-SMLO · Traditional | Cardiocalm | 08/26/2020SE |
| K182030 | Faros MobileMLO · Abbreviated | Bittium Biosignals , Ltd. | 11/08/2018SE |
| K140847 | Cardiospy ECG Holter SystemsMLO · Traditional | Labtech Kft. | 12/05/2014SE |
| K131897 | CV3000 Holter Analysis SystemMLO · Traditional | Vales & Hills Biomedical Tech. , Ltd. | 11/26/2013SE |
| K130660 | Audicor Cpam with SDB (Single Sensor)MLO · Traditional | Inovise Medical, Inc. | 10/11/2013SE |
| K111487 | NH-301 Ambulatory ECG Analysis SoftwareMLO · Special | Norav Medical Corp. | 11/10/2011SE |
More from Norav Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K151433 | AUDICOR CA300/CC100 Analyzer with SDBMNR · Traditional | 03/18/2016SE |
| K131883 | Audicor Cpam with SDB (Accelerometer Based)MNR · Traditional | 04/11/2014SE |
| K130660 | Audicor Cpam with SDB (Single Sensor)MLO · Traditional | 10/11/2013SE |
| K110569 | Audicor Cpam (Cardiopulmonary Ambulatory Monitor)MLO · Traditional | 10/24/2011SE |
| K103516 | Audicor Sensor-Adapter Model Audicor Sensor-Adapter 4.0DQD · Traditional | 02/04/2011SE |
| K080602 | Audicor Sensor, Models: 2.0, 3.0DRX · Traditional | 09/25/2008SE |
| K073545 | Audicor, Hemo Ambulatory MonitorMWJ · Traditional | 09/09/2008SE |
| K070136 | Audicor 200 System, Models 200D and 200SDPS · Traditional | 04/13/2007SE |
| K051450 | Extended Measurements SystemDQD · Traditional | 11/10/2005SE |
| K043074 | Liberty SystemDPS · Traditional | 02/22/2005SE |
Questions and answers
When was Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered Breathing Detection) cleared by the FDA?
Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered Breathing Detection) (K120462) received a 510(k) decision of Substantially Equivalent on September 20, 2012, 218 days after the submission was received.
What is the product code of K120462?
The FDA product code is MLO – Electrocardiograph, Ambulatory, With Analysis Algorithm, a Class II (moderate risk) device regulated under 21 CFR 870.2800.