2010 Plus Holter for Windows
FDA 510(k) K003940 · Agilent Technologies
510(k) numberK003940
Submission
- Device name
- 2010 Plus Holter for Windows
- Applicant
- Agilent Technologies
Oxnard, CA, US - Received
- December 21, 2000
- Decision date
- February 8, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K120462 | Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…MLO · Traditional | Inovise Medical, Inc. | 09/20/2012SE |
More from Inovise Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K163367 | GenetiSure Dx Postnatal AssayPFX · Traditional | 08/11/2017SE |
| K010949 | 2010 Plus Holter for WindowsMLO · Traditional | 09/28/2001SE |
| K012094 | Modification to Device Link System, Model M2376AMWI · Special | 07/20/2001SE |
| K011824 | Agilent M2636B Telemon B Monitor (Telemon B)DSI · Special | 07/02/2001SE |
| K010634 | Heartstream XL Defibibrillator/Monitor, Model M4735A, Heartstream XLT…MKJ · Traditional | 06/11/2001SE |
| K011578 | M2376A Devicelink System, Model M2376AMWI · Special | 06/08/2001SE |
| K003819 | Heartstream Attenuated Defibrillation Pads, Model M3870AMKJ · Traditional | 05/02/2001SE |
| K011093 | Agilent Information Center Software for M3150,M3151,M3153 and M3154MHX · Special | 05/01/2001SE |
| K010453 | M2376A Devicelink SystemMWI · Special | 03/02/2001SE |
| K010342 | M2376A Devicelink System, Model M2376AMWI · Special | 02/14/2001SE |
Questions and answers
When was 2010 Plus Holter for Windows cleared by the FDA?
2010 Plus Holter for Windows (K003940) received a 510(k) decision of Substantially Equivalent on February 8, 2001, 49 days after the submission was received.
What is the product code of K003940?
The FDA product code is MLO – Electrocardiograph, Ambulatory, With Analysis Algorithm, a Class II (moderate risk) device regulated under 21 CFR 870.2800.