Verifine® Ease Lancing Device, Verifine® Lancing Device— 510(k) K223643

Substantially Equivalent

Promisemed Hangzhou Meditech Co., Ltd.

FDA 510(k) clearance K223643 for Verifine® Ease Lancing Device, Verifine® Lancing Device, Substantially Equivalent on 2023-02-21. Applicant: Promisemed Hangzhou Meditech Co., Ltd..

Clearance details

Applicant
Promisemed Hangzhou Meditech Co., Ltd.
Product code
Code QRL
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hangzhou City, CN
Download summary PDFView on FDA.gov ↗

Adverse events under product code QRL

product code QRL
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.