510(k) K033030
- Device
- CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM
- Applicant
- WITT BIOMEDICAL CORP
- 510(k) number
- K033030
- Product code
- MWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-02-24
- Date received
- 2003-09-26
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ELFRIEDE PAGAN
- Address
- 305 N. Dr. Melbourne FL US 32934 32934
FDA Registration Numbers#
- 3021219789
- 3009327812
- 3003768277
- 2032233
- 3007134734
- 3030447506
- 3021343210
- 3023412068
- 3008787503
- 2011171
- 3013500228
- 3000126629
- 3012528160
- 1054713
- 3012251275
- 3008365372
- 3007029079
- 3010041430
- 3016674095
- 9610105
- 3005569927
- 3010716438
- 1066427
- 8043459
- 1000122786
- 3012359877
- 3010824458
- 3009959868
- 3019388613
- 3031563234
- 3033715634
- 3014886121
- 3006648320
- 1523530
- 3011200896
- 3007603826
- 3004145393
- 8021084
- 3003630387
- 3008283443
- 3043668257
- 1930027
- 3003971136
- 3014856521
- 3016931915
- 1222630
- 3006104191
- 3002736372
- 2936999
- 3012103976
- 3022425463
- 1316463
- 3010097171
- 3009001657
- 3029871637
- 8040537
- 9615102
- 3024491912
- 3010419931
- 3008716327
- 3004009431
- 3009499478
- 3015529350
- 3011651230
- 3012421607
- 3004415095
- 3037341611
- 3043543260
- 3004091281
- 3014128039
- 9710602
- 3010032903
- 3006979678
- 1051786
- 3011359729
- 3042175844
- 3008255748
- 8020045
- 3004906872
- 3006808382
Source Documents#
510(k) summary PDF not indicated by FDA
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases