NR Recorder
FDA 510(k) K161062 · Norav Medical GmbH
510(k) numberK161062
Submission
- Device name
- NR Recorder
- Applicant
- Norav Medical GmbH
Wiesbaden, DE - Received
- April 15, 2016
- Decision date
- June 13, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MWJ – Electrocardiograph, Ambulatory (Without Analysis)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
Other 510(k)s with product code MWJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254119 | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…MWJ · Traditional | Shenzhen Xinyan Medical Technology Co.,ltd. | 09/11/2026SE |
| K253529 | Peerbridge COR MDx (Cor MDx)MWJ · Abbreviated | Peerbridge Health, Inc. | 09/04/2026SE |
| K253562 | medilogFDMWJ · Traditional | Schiller AG | 08/14/2026SE |
| K253384 | mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7…MWJ · Traditional | Seers Technology Co., Ltd. | 06/25/2026SE |
| K252839 | ZywieZ3 Sensor & AdhesiveMWJ · Traditional | Zywie, Inc. | 06/18/2026SE |
| K231424 | HeartBeam AIMIGo(TM) SystemMWJ · Traditional | Heartbeam, Inc. | 12/13/2024SE |
| K233864 | ASSURE Wearable ECGMWJ · Traditional | Kestra Medical Technologies, Inc. | 05/07/2024SE |
| K212317 | Eclipse MINI Model 98900MWJ · Traditional | Spacelabs Healthcare, Ltd. | 11/07/2022SE |
| K222017 | BiotresMWJ · Special | Biotricity | 07/28/2022SE |
| K210758 | Q PatchMWJ · Traditional | Medicalgorithmics S.A. | 06/02/2022SE |
More from Medicalgorithmics S.A.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K012712 | Norav Holter System, Model NH-300 V1.07MLO · Traditional | 05/08/2002SE |
| K000404 | PC ECG 1200MWI · Traditional | 11/22/2000SE |
Questions and answers
When was NR Recorder cleared by the FDA?
NR Recorder (K161062) received a 510(k) decision of Substantially Equivalent on June 13, 2016, 59 days after the submission was received.
What is the product code of K161062?
The FDA product code is MWJ – Electrocardiograph, Ambulatory (Without Analysis), a Class II (moderate risk) device regulated under 21 CFR 870.2800.