Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK
FDA 510(k) clearance K181541 · decided 2019-04-16
Clearance details
- K-number
- K181541
- Device name
- Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK
- Applicant
- Andon Health Co, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-06-11
- Decision date
- 2019-04-16
- Days to decision
- 309 days
- Clearance type
- Traditional
- Product code
- MWI
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tianjin, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Andon Health Co
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 |
|---|---|---|
| Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) (K253196) | Midmark Corporation | 2026-06-12 |
| c-med0 alpha (K253436) | Cosinuss GmbH | 2026-04-30 |
| WAVE Clinical Platform (2.0.000) (K250135) | Baxter Healthcare Corp/ Excel Medical | 2026-01-16 |
| QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) (K241766) | Fysicon BV | 2025-08-27 |
| 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.