Audicor Cpam with SDB (Single Sensor)
FDA 510(k) K130660 · Inovise Medical, Inc.
510(k) numberK130660
Submission
- Device name
- Audicor Cpam with SDB (Single Sensor)
- Applicant
- Inovise Medical, Inc.
Beaverton, OR, US - Received
- March 12, 2013
- Decision date
- October 11, 2013
- 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 |
| K120462 | Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…MLO · Traditional | Inovise Medical, Inc. | 09/20/2012SE |
| 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 |
| K120462 | Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…MLO · Traditional | 09/20/2012SE |
| 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 (Single Sensor) cleared by the FDA?
Audicor Cpam with SDB (Single Sensor) (K130660) received a 510(k) decision of Substantially Equivalent on October 11, 2013, 213 days after the submission was received.
What is the product code of K130660?
The FDA product code is MLO – Electrocardiograph, Ambulatory, With Analysis Algorithm, a Class II (moderate risk) device regulated under 21 CFR 870.2800.