510(k) K101264
- Device
- TEMPUS IC PROFESSIONAL PATIENT MONITOR
- Applicant
- REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
- 510(k) number
- K101264
- Product code
- MWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-05-11
- Date received
- 2010-05-05
- 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
- Yes
Applicant Contact#
- Contact
- CHRIS HANNAN
- Address
- The Old Coach House, The Av. Farleigh Wallop, Basingstoke Hampshire GB RG25 2HT RG25 2HT
FDA Registration Numbers#
- 3015529350
- 3004145393
- 3021343210
- 3011683100
- 1220908
- 9710602
- 3042175844
- 3003768277
- 3006146787
- 3013896610
- 3024491912
- 3007137598
- 8030229
- 3007836437
- 3014579161
- 3035111606
- 3007413079
- 1066427
- 3012251275
- 3006546174
- 3010863450
- 3013500228
- 3010392999
- 3008283443
- 3011359729
- 3021632375
- 3013501110
- 1062836
- 1833920
- 2027454
- 3013557562
- 3016852448
- 3007603826
- 3006240053
- 3009831876
- 2221819
- 8022257
- 8020045
- 3003174284
- 3003832357
- 3011353843
- 3016670256
- 3002736372
- 8010482
- 8040537
- 3007481893
- 3018514222
- 1651104
- 3031563234
- 3003630387
- 3005569927
- 3009959868
- 3037341611
- 3020476987
- 3033959233
- 3008164770
- 3010120135
- 3016674095
- 3007134734
- 2080783
- 3000130829
- 3010157426
- 3027256461
- 1222630
- 3017059349
- 3004415095
- 2520313
- 3008729547
- 3047896295
- 9680215
- 3012103976
- 2936999
- 9610105
- 3029871637
- 3009156722
- 8040564
- 1930027
- 2183613
- 3010120148
Source Documents#
Other 510(k) Records For Product Code MWI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260438 | Vital Signs Monitor (CLEO2) | Infinium Medical, Inc. | 2026-08-14 |
| K253417 | Masimo Root Monitoring System | Masimo Corporation | 2026-08-12 |
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | Midmark Corporation | 2026-06-12 |
| 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 |
Legacy Summary#
summary
FDA Review#
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