510(k) K203208
- Device
- Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System
- Applicant
- Taiwan Aulisa Medical Devices Technologies, Inc.
- 510(k) number
- K203208
- Product code
- MSX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-06-12
- Date received
- 2020-10-30
- Regulation
- 870.2300
- Classification name
- System, Network And Communication, Physiological Monitors
- Medical specialty
- Cardiovascular
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Paul Liu
- Address
- Rm. 1052, Bldg. H, 10f., # 3-2, Yuanqu St., Nangang Dist. Taipei TW 115 115
FDA Registration Numbers#
- 3015181391
- 1423537
- 3010984687
- 3006636961
- 3003674698
- 1066270
- 9614683
- 3010827261
- 3010288146
- 3010834934
- 3015997711
- 3006125362
- 3008505660
- 9681377
- 3012977166
- 3003879246
- 3007358963
- 3004091281
- 2183613
- 3013652261
- 3013596024
- 3013500228
- 9610816
- 9680215
- 3015134004
- 1063285
- 3015697152
- 1217183
- 3009673645
- 3015109923
- 9617543
- 3008483389
- 9611031
- 3009617411
- 3013826848
- 2123774
- 3013426279
- 8030978
- 3008164770
- 3016931915
- 3037341611
- 3007413079
- 8010482
- 3021691064
- 3010838917
- 3030733800
- 3004415095
- 3005798905
- 1651104
- 3008830133
- 3011420269
- 3003971136
- 3016171841
- 3012104670
- 3011200896
- 3030149975
- 3010381606
- 3021559257
- 3012804266
- 3010536822
- 3012678246
- 3007607999
- 3013116677
- 3011353843
- 3032109181
- 3000126629
- 3004145393
- 3015967131
- 2939821
- 3007699081
- 3015455735
- 1713468
- 1054713
- 1000122786
- 3034603279
- 3009142030
- 2081040
- 3012337868
- 3030447506
Source Documents#
Other 510(k) Records For Product Code MSX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253654 | IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Böblingen GmbH | 2026-03-30 |
| K243270 | TigerConnect Alarm Management | Tigerconnect | 2025-09-30 |
| K242728 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-07-31 |
| K242750 | Central Station | Nihon Kohden Digital Health Solutions, LLC | 2025-06-05 |
| K242842 | ANNE View, Central Hub | Sibel Health, Inc. | 2025-01-08 |
| K241397 | Hinscope | Hinlab Sas | 2024-11-14 |
| K233834 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2024-07-12 |
| K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | 2024-05-09 |
| K232548 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2024-03-22 |
| K231506 | Current Health System | Current Health , Ltd. | 2023-08-24 |
| K223567 | CNS-2101 Central Monitor | Nihon Kohden Corporation | 2023-07-31 |
| K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | 2023-02-23 |
| K222550 | Current Health System | Current Health , Ltd. | 2022-11-01 |
| K203579 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2022-06-07 |
| K211046 | eCareManager 4.5 | Visicu, Inc. | 2022-06-03 |
Legacy Summary#
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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