Hokanson

D.E.HOKANSON, INC. · Model MD35 · UDI-DI 00817065021389

510(k) clearances

Adverse events

Recalls

Facilities

Description

DOPPLER AND PLETHYSMOGRAPH SYSTEM - The line-powered instrument contains a direction-sensing continuous wave Doppler, a photo plethysmograph, and a pneumo plethysmograph. Several types of diagnostic tests can be performed allowing the user to choose the most appropriate one for the particular study of interest. A built-in two speed chart recorder can record the waveform from the selected instrument mode. A digital output is included so waveforms can also be captured in computer software.

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

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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.