Eclipse PRO
FDA 510(k) K211651 · Spacelabs Healthcare, Ltd.
510(k) numberK211651
Submission
- Device name
- Eclipse PRO
- Applicant
- Spacelabs Healthcare, Ltd.
Hertford, GB - Received
- May 28, 2021
- Decision date
- November 22, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K212317 | Eclipse MINI Model 98900MWJ · Traditional | 11/07/2022SE |
| K201921 | Spacelabs Lifescreen PRO AnalyzerDQK · Traditional | 03/26/2021SE |
| K152881 | Sentinel Cardiology Information Management SystemDQK · Traditional | 04/01/2016SE |
| K150329 | elance Vital Signs Monitor, Central Monitor SoftwareMHX · Traditional | 11/05/2015SE |
| K141113 | Spacelbs Model on Trak (90227) Ambulatory Bloody Pressure (Abp) Non-InvasiveDXN · Special | 09/26/2014SE |
| K141156 | Spacelabs Healthcare Telemetry ReceiverMHX · Traditional | 09/09/2014SE |
| K130207 | Spacelabs Healthcare CardioexpressDPS · Traditional | 07/23/2013SE |
| K122146 | Xhibit Central Station, Model 96102MHX · Traditional | 04/22/2013SE |
| K130112 | Capno Module, 92517CCK · Special | 03/21/2013SE |
| K121017 | Capnography Pad (92516)CCK · Special | 07/13/2012SE |
Questions and answers
When was Eclipse PRO cleared by the FDA?
Eclipse PRO (K211651) received a 510(k) decision of Substantially Equivalent on November 22, 2021, 178 days after the submission was received.
What is the product code of K211651?
The FDA product code is MWJ – Electrocardiograph, Ambulatory (Without Analysis), a Class II (moderate risk) device regulated under 21 CFR 870.2800.