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

Name: FDA 510(k) clearance K100524
Creator: U.S. Food and Drug Administration
Published: 2010-05-24

Substantially Equivalent

Polymap Wireless, LLC

FDA 510(k) clearance K100524 for POLYTEL(R) APT MODEL: PWA-08-01, Substantially Equivalent on 2010-05-24. Applicant: Polymap Wireless, LLC. Device class: 2.

Clearance details

Applicant: Polymap Wireless, LLC
Product code: Product code DRG
Device class: Class 2
Regulation: 21 CFR 870.2910
Advisory panel: Cardiovascular
Date received: 2010-02-24
Decision date: 2010-05-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

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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.