Hokanson

FDA UDI

Class II (US FDA UDI)

by D. E. Hokanson, Inc.

Identity

Trade Name: Hokanson FDA UDI
Generic Name: Plethysmography phototransducer FDA UDI
Device Name: PHOTOTRANSDUCER; 4 PIN CONNECTOR - 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 FDA UDI
Description: PHOTOTRANSDUCER; 4 PIN CONNECTOR - 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: 01543 FDA UDI
Primary DI / UDI-DI: 00817065021433 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: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Hokanson by D. E. Hokanson, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 2e109b1c-14b7-433d-8052-ad3b95353835 37 fields · synced Jun 8, 2026