Unity Network ID
FDA 510(k) clearance K142840 · decided 2015-01-07
Clearance details
- K-number
- K142840
- Device name
- Unity Network ID
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2014-09-30
- Decision date
- 2015-01-07
- Days to decision
- 99 days
- Clearance type
- Special
- Product code
- MWI
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
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| WAVE Clinical Platform (2.0.000) (K250135) | Baxter Healthcare Corp/ Excel Medical | 2026-01-16 |
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| Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (K242737) | Empatica S.r.l. | 2025-06-06 |
| WARD-CSS (v1.2.x) (K241958) | Ward 24/7 Aps | 2025-02-14 |
| iCare APP (K243146) | Ihealth Labs, Inc. | 2025-02-03 |
| Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (K241411) | Welch Allyn, Inc. | 2024-12-20 |
| Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) (K243216) | Analog Devices | 2024-12-10 |
| AMC Health CareConsole (K233446) | Amc Health | 2024-09-27 |
| Happy Ring Health Monitoring System (K240236) | Happy Health, Inc. | 2024-09-24 |
| WVSM Pro (Series) (500-0030-XX) (K233354) | Athena Gtx, Inc. | 2024-06-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Senographe Pristina 3D (P130020/S005) | GE Healthcare | 2025-11-21 |
| Invenia ABUS Premium, Invenia ABUS Prime (P110006/S011) | GE Healthcare | 2025-02-04 |
| Senographe Pristina 3D and SenoClaire (P130020/S004) | GE Healthcare | 2021-03-23 |
| Invenia ABUS (Automated Breast Ultrasound System) 2.0 (P110006/S010) | GE Healthcare | 2018-08-24 |
| Invenia ABUS 2.0 Automated Breast Ultrasound System (P110006/S009) | GE Healthcare | 2018-05-11 |
| Senographe Pristina 3D (P130020/S003) | GE Healthcare | 2017-12-28 |
| Invenia ABUS Autoated Breast Ultrasound System (P110006/S008) | GE Healthcare | 2017-09-07 |
| Invenia ABUS - Automated Breast Ultrasound System (P110006/S007) | GE Healthcare | 2017-05-01 |