Identity
- Trade Name
- DaliaSense FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- A Bluetooth blood pressure monitor compatible with the DaliaHealth platform, measuring heart rate, diastolic and systolic blood pressure, and an AI analysis for irregular heartbeats. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- A Bluetooth blood pressure monitor compatible with the DaliaHealth platform, measuring heart rate, diastolic and systolic blood pressure, and an AI analysis for irregular heartbeats. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860011532828 FDA UDI
- 510(k) Number
- K193348 FDA UDI
- FDA Product Code
- DXN FDA UDIDPS FDA UDI
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 FDA UDI870.2340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
DaliaSense by Stethoai LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Automatic-inflation electronic sphygmomanometer, portable, arm/wrist.
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- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- BRIGHT LIFE — Shenzhen Urion Technology Co., Ltd. · Class II
- RemoteCare 4U — Guangdong Transtek Medical Electronics Co., Ltd · Class II
- Omron 3 Series Upper Arm Blood Pressure Monitor — Omron Healthcare, Inc. · Class II
Cleared under the same submission
K193348 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Stethoai LLC
Sources (1)
- FDA UDI 54f70f44-3bba-49d8-b098-842db8c5e10c 34 fields · synced May 31, 2026