510(k) K211651
- Device
- Eclipse PRO
- Applicant
- Spacelabs Healthcare, Ltd.
- 510(k) number
- K211651
- Product code
- MWJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-11-22
- Date received
- 2021-05-28
- Regulation
- 870.2800
- Classification name
- Electrocardiograph, Ambulatory (Without Analysis)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Roger Moldon
- Address
- Unit B, Foxholes Centre John Tate Rd. Hertford GB SG13 7DT SG13 7DT
FDA Registration Numbers#
- 3010082909
- 3007184699
- 3012528160
- 3016406615
- 1224919
- 3014235520
- 3013596024
- 2028530
- 3013500228
- 3012027770
- 3008717264
- 9681548
- 3006087789
- 1000122786
- 3015185344
- 3010157426
- 3014848734
- 3008159616
- 3013889955
- 3035371769
- 3009443693
- 3008413470
- 3004009431
- 3003971136
- 3016701404
- 1316463
- 3011883032
- 3009499478
- 3009077524
- 3004035727
- 3016618143
- 3010381606
- 3010390468
- 3017446092
- 3015529350
- 3032906215
- 1218950
- 1126271
- 1000165971
- 1527715
- 9611295
- 3008977358
- 3004006614
- 3007770164
- 3043479346
- 2133641
- 3010552191
Source Documents#
Other 510(k) Records For Product Code MWJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231424 | HeartBeam AIMIGo(TM) System | Heartbeam, Inc. | 2024-12-13 |
| K233864 | ASSURE Wearable ECG | Kestra Medical Technologies, Inc. | 2024-05-07 |
| K212317 | Eclipse MINI Model 98900 | Spacelabs Healthcare, Ltd. | 2022-11-07 |
| K222017 | Biotres | Biotricity | 2022-07-28 |
| K210758 | Q Patch | Medicalgorithmics S.A. | 2022-06-02 |
| K211709 | Biotres | Biotricity | 2022-01-19 |
| K173156 | Integrated CardioRespiratory System | Sensydia, Inc. | 2018-06-08 |
| K161062 | NR Recorder | Norav Medical GmbH | 2016-06-13 |
| K152626 | H3+ Holter Recorder | Mortara Instrument, Inc. | 2016-02-26 |
| K142424 | DR300 HOLTER MONITOR | North East Monitoring, Inc. | 2014-11-25 |
| K133014 | DMS 300-2W HOLTER ECG RECORDER | Diagnostic Monitoring Software | 2014-05-19 |
| K130294 | BRAEMAR CARDIOKEY HOLTER RECORDER | Braemar Manufacturing, LLC | 2013-10-16 |
| K130785 | SEER 1000 | Getemed Medizin- Und Informationstechnik AG | 2013-07-26 |
| K122272 | CARDIOMEM | Getemed Medizin- Und Informationstechnik AG | 2013-03-28 |
| K112573 | EZSLEEP SLEEP QUALITY RECORDER | Platinum Team Co., Ltd. | 2012-03-22 |