Hokanson

D.E.HOKANSON, INC. · Model PPG sensor 4 Pin - EC6 · UDI-DI 00817065022492

510(k) clearances

Adverse events

Recalls

Facilities

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.

Recalls

Date	Firm	Reason
2022-09-02	Baxter Healthcare Corporation	Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
2015-12-01	Partners In Medicine Llc	Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure values in some subjects - mainly in tall and slim persons (overestimation

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.