DeviceClearance

ACTITRAINER— 510(k) K080545

Substantially Equivalent

Actigraph, LLC

FDA 510(k) clearance K080545 for ACTITRAINER, Substantially Equivalent on 2008-07-24. Applicant: Actigraph, LLC.

Clearance details

Applicant
Actigraph, LLC
Product code
Code ISD
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pensacola, FL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ISD

product code ISD
Other
2
Total
2

Source: openFDA MAUDE database, through . 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.