PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6— 510(k) K131558

Substantially Equivalent

Shenzhen Pango Electronic Co., Ltd.

FDA 510(k) clearance K131558 for PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6, Substantially Equivalent on 2013-08-30. Applicant: Shenzhen Pango Electronic Co., Ltd..

Clearance details

Applicant: Shenzhen Pango Electronic Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2013-05-30
Decision date: 2013-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhenzhen, Guangdong, CN

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Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.