Identity
- Trade Name
- Fingerclip PPG sensor FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- The Fingerclip PPG sensor is similar in enclosure to a standard pulse oximeter. It is designed primarily to fit comfortably to the fingers. It measures the photoplethysmograph signals as a reference of blood flow for evaluation of segmental blood pressures or other peripheral vascular diagnosis tests FDA UDI
- Model / Reference
- Fingerclip PPG sensor FDA UDI
- Description
- The Fingerclip PPG sensor is similar in enclosure to a standard pulse oximeter. It is designed primarily to fit comfortably to the fingers. It measures the photoplethysmograph signals as a reference of blood flow for evaluation of segmental blood pressures or other peripheral vascular diagnosis tests FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016880182 FDA UDI
- 510(k) Number
- K111416 FDA UDI
- FDA Product Code
- JOP FDA UDI
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2880 FDA UDI
- Commercial Distribution
- Not 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Fingerclip PPG sensor by Viasonix Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K111416 also covers:
- 4 MHz probe — VIASONIX LTD
- 8 MHz probe — VIASONIX LTD
- Pressure Cuff Size 1.6 — VIASONIX LTD
- Pressure Cuff Size 1.9 — VIASONIX LTD
- Pressure Cuff Size 10 — VIASONIX LTD
- Pressure Cuff Size 12 — VIASONIX LTD
- Pressure Cuff Size 12L — VIASONIX LTD
- Pressure Cuff Size 2.5 — VIASONIX LTD
- Pressure Cuff Size 7 — VIASONIX LTD
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Viasonix Ltd
Sources (1)
- FDA UDI 4d829c78-cd78-4902-881b-cf69f74af1b6 35 fields · synced May 30, 2026