510(k) K193009— Promisemed Heel Blood Lancet

Substantially Equivalent

Promisemed Hangzhou Meditech Co., Ltd.

Clearance details

Applicant: Promisemed Hangzhou Meditech Co., Ltd.
Product code: Code FMK
Advisory panel: General, Plastic Surgery
Date received: 2019-10-28
Decision date: 2019-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou City, CN

Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.