DUAL SHOT ALPHA 7— 510(k) K133189

Substantially Equivalent

Nemoto Kyorindo Co., Ltd.

FDA 510(k) clearance K133189 for DUAL SHOT ALPHA 7, Substantially Equivalent on 2014-06-30. Applicant: Nemoto Kyorindo Co., Ltd..

Clearance details

Applicant: Nemoto Kyorindo Co., Ltd.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2013-10-17
Decision date: 2014-06-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Bunkyo-Ku, JP

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.