Norav Holter System, Model NH-300 V1.07
FDA 510(k) K012712 · Norav Medical , Ltd.
510(k) numberK012712
Submission
- Device name
- Norav Holter System, Model NH-300 V1.07
- Applicant
- Norav Medical , Ltd.
Plymouth, MN, US - Received
- August 14, 2001
- Decision date
- May 8, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K161062 | NR RecorderMWJ · Traditional | 06/13/2016SE |
| K111487 | NH-301 Ambulatory ECG Analysis SoftwareMLO · Special | 11/10/2011SE |
| K110463 | PCECG-1200 System with Modular ECG Analysis System (Means)MWI · Special | 11/10/2011SE |
| K080141 | PC ECG 1200W SystemMWI · Special | 04/25/2008SE |
| K000404 | PC ECG 1200MWI · Traditional | 11/22/2000SE |
Questions and answers
When was Norav Holter System, Model NH-300 V1.07 cleared by the FDA?
Norav Holter System, Model NH-300 V1.07 (K012712) received a 510(k) decision of Substantially Equivalent on May 8, 2002, 267 days after the submission was received.
What is the product code of K012712?
The FDA product code is MLO – Electrocardiograph, Ambulatory, With Analysis Algorithm, a Class II (moderate risk) device regulated under 21 CFR 870.2800.