510(k) K100524— POLYTEL(R) APT MODEL: PWA-08-01

Substantially Equivalent

Polymap Wireless, LLC

Clearance details

Applicant: Polymap Wireless, LLC
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2010-02-24
Decision date: 2010-05-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tucson, AZ, US

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.