Holter Recorder H3+
FDA 510(k) K043010 · Mortara Instrument, Inc.
510(k) numberK043010
Submission
- Device name
- Holter Recorder H3+
- Applicant
- Mortara Instrument, Inc.
Milwaukee, WI, US - Received
- November 1, 2004
- Decision date
- February 25, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K182297 | Surveyor S2DRG · Traditional | 01/24/2019SE |
| K173765 | Surveyor Patient MonitorMHX · Traditional | 09/04/2018SE |
| K161517 | Mortara Surveyor Patient MonitorMHX · Traditional | 01/11/2017SE |
| K161465 | CardioConfirmDQK · Traditional | 09/03/2016SE |
| K160685 | Surveyor S4 Mobile MonitorMHX · Traditional | 08/04/2016SE |
| K152626 | H3+ Holter RecorderMWJ · Traditional | 02/26/2016SE |
| K152944 | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing SystemsDPS · Traditional | 01/06/2016SE |
| K141020 | Surveyor S4 Mobile MonitorDRG · Traditional | 12/03/2014SE |
| K133989 | Ambulo 2400 Ambulatory Blood Pressure Monitoring SystemDXN · Abbreviated | 11/25/2014SE |
| K141811 | Mortara Monitoring Waveform ViewerMHX · Abbreviated | 11/19/2014SE |
Questions and answers
When was Holter Recorder H3+ cleared by the FDA?
Holter Recorder H3+ (K043010) received a 510(k) decision of Substantially Equivalent on February 25, 2005, 116 days after the submission was received.
What is the product code of K043010?
The FDA product code is MWJ – Electrocardiograph, Ambulatory (Without Analysis), a Class II (moderate risk) device regulated under 21 CFR 870.2800.