MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS
FDA 510(k) clearance K012171 · decided 2001-07-24
Clearance details
- K-number
- K012171
- Device name
- MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS
- Applicant
- Visicu, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-12
- Decision date
- 2001-07-24
- Days to decision
- 12 days
- Clearance type
- Special
- Product code
- MSX
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Baltimore, MD, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Visicu
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Corsano CardioWatch 287-2 System (K261367) | Corsano Health B.V. | 2026-07-26 |
| IntelliVue Measurement Rack 6000 (867317) (K253654) | Philips Medizin Systeme Böblingen GmbH | 2026-03-30 |
| TigerConnect Alarm Management (K243270) | Tigerconnect | 2025-09-30 |
| BeneVision Central Monitoring System (K242728) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-07-31 |
| Central Station (K242750) | Nihon Kohden Digital Health Solutions, LLC | 2025-06-05 |
| ANNE View, Central Hub (K242842) | Sibel Health, Inc. | 2025-01-08 |
| Hinscope (K241397) | Hinlab Sas | 2024-11-14 |
| Infinity Gateway Suite (K233834) | Draeger Medical Systems, Inc. | 2024-07-12 |
| Biofourmis Everion+ (G2) (K233418) | Biofourmis Singapore Pte., Ltd. | 2024-05-09 |
| Corsano CardioWatch 287-2 System (K232548) | Corsano Health B.V. | 2024-03-22 |
| Current Health System (K231506) | Current Health , Ltd. | 2023-08-24 |
| CNS-2101 Central Monitor (K223567) | Nihon Kohden Corporation | 2023-07-31 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The eCareManager system. Software intended for use in data collection, storage and clinica recall (Z-0399-2016) | Visicu, Inc. | 2015-12-10 |
| Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. Product U recall (Z-1474-2012) | Visicu, Inc. | 2012-04-27 |