Identity
- Trade Name
- Hokanson FDA UDI
- Generic Name
- Plethysmography phototransducer FDA UDI
- Device Name
- PHOTOTRANSDUCER; 4 PIN CONNECTOR EC6 - A plethysmograph sensor that attaches to an electronic plethysmograph instrument, used to measure volume changes due to blood flow changes in a limb or digit. The plethysmograph instrument measures the signal to determine changes in blood volume in the tissue under the sensor. FDA UDI
- Model / Reference
- PPG sensor 4 Pin - EC6 FDA UDI
- Description
- PHOTOTRANSDUCER; 4 PIN CONNECTOR EC6 - A plethysmograph sensor that attaches to an electronic plethysmograph instrument, used to measure volume changes due to blood flow changes in a limb or digit. The plethysmograph instrument measures the signal to determine changes in blood volume in the tissue under the sensor. FDA UDI
Identifiers
- Catalog Number
- 01547 FDA UDI
- Primary DI / UDI-DI
- 00817065022492 FDA UDI
- 510(k) Number
- K896034 FDA UDI
- FDA Product Code
- DSB FDA UDI
- GMDN Term
- Plethysmography phototransducer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2770 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
No
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
No
FDA UDI
Category: Plethysmography phototransducer
Hokanson by D. E. Hokanson, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Plethysmography phototransducer.
- Finger Plethysmograph (Model MC2, AngioNew® V& VI) — VASOMEDICAL, INC. · Class II
- BiDop 7 probe — Koven Technology, Inc. · Class II
- Finger Plethysmograph (Models TS3 and TS4) — VASOMEDICAL, INC. · Class II
- Hokanson — D. E. Hokanson, Inc. · Class II
- Hokanson — D. E. Hokanson, Inc. · Class II
Cleared under the same submission
K896034 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
- D. E. Hokanson, Inc.
Sources (1)
- FDA UDI 54e8dcbc-1269-42b9-868d-8720a2cf5042 36 fields · synced Jun 8, 2026