510(k) K152124
- Device
- Tempus IC2
- Applicant
- REMOTE DIAGNOSTICS TECHNOLOGIES LTD
- 510(k) number
- K152124
- Product code
- MWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-10-28
- Date received
- 2015-07-31
- Regulation
- 870.2300
- Classification name
- Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRIS HANNAN
- Address
- The Old Coach House, The Ave., Farleigh Wallop Basingstoke GB RG25 2HT RG25 2HT
FDA Registration Numbers#
- 3012421607
- 3024491912
- 3007029079
- 1222630
- 8040537
- 3016852448
- 3010392999
- 3012359877
- 3013188547
- 1064859
- 3016931915
- 3000130829
- 3002736372
- 3009499478
- 3021343210
- 3012238587
- 3005521864
- 3016674095
- 3006606827
- 3030447506
- 1930027
- 3011683100
- 3006733253
- 3007413079
- 1000122786
- 3010419931
- 3003630387
- 8022257
- 3006104191
- 3005803793
- 3019388613
- 8040564
- 3009001657
- 3010317211
- 3014579161
- 3043543260
- 3027256461
- 9610816
- 3021632375
- 3020476987
- 2011171
- 3003591740
- 3003174284
- 3008283443
- 3013298431
- 3012528160
- 1833920
- 3038259592
- 3010863450
- 3007481893
- 3014856521
- 2952596
- 3018514222
- 3008255748
- 3003681187
- 3006146787
- 3007603826
- 8021084
- 3004009431
- 1054713
- 3007134734
- 3043668257
- 3034603598
- 3035111606
- 3006808382
- 3006979678
- 3033715634
- 3003294644
- 3003832357
- 3007836437
- 3013557562
- 3008253300
- 3009077524
- 3009327812
- 1066427
- 1651104
- 3008365372
- 3011651230
- 3003971136
- 3016618143
Source Documents#
Other 510(k) Records For Product Code MWI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253436 | c-med0 alpha | Cosinuss GmbH | 2026-04-30 |
| K250135 | WAVE Clinical Platform (2.0.000) | Baxter Healthcare Corp/ Excel Medical | 2026-01-16 |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | Fysicon BV | 2025-08-27 |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2025-06-06 |
| K241958 | WARD-CSS (v1.2.x) | Ward 24/7 Aps | 2025-02-14 |
| K243146 | iCare APP | Ihealth Labs, Inc. | 2025-02-03 |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | Welch Allyn, Inc. | 2024-12-20 |
| K243216 | Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) | Analog Devices | 2024-12-10 |
| K233446 | AMC Health CareConsole | Amc Health | 2024-09-27 |
| K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | 2024-09-24 |
| K233354 | WVSM Pro (Series) (500-0030-XX) | Athena Gtx, Inc. | 2024-06-26 |
| K232111 | NeoBeat, NeoBeat Mini | Laerdal Medical AS | 2024-06-25 |
| K233810 | Portrait VSM | Ge Medical Systems Information Technologies, Inc. | 2024-04-25 |
| K233133 | Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical, LLC | 2024-04-01 |
| K234130 | Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse O | Ge Medical Systems Information Technologies, Inc. | 2024-03-20 |
Legacy Summary#
summary
FDA Review#
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