DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH— 510(k) K051357

Substantially Equivalent

Digitimer , Ltd.

FDA 510(k) clearance K051357 for DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH, Substantially Equivalent on 2005-09-20. Applicant: Digitimer , Ltd..

Clearance details

Applicant: Digitimer , Ltd.
Product code: Code GWF
Advisory panel: Neurology
Date received: 2005-05-24
Decision date: 2005-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lauderdale, FL, US

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Adverse events under product code GWF

product code GWF

Malfunction: 2,364
Other: 4
Total: 2,368

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.