PROWLER SELECT PLUS; PROWLER EX— 510(k) K210838

Name: FDA 510(k) clearance K210838
Creator: U.S. Food and Drug Administration
Published: 2021-08-25

Substantially Equivalent

Medos International SARL

FDA 510(k) clearance K210838 for PROWLER SELECT PLUS; PROWLER EX, Substantially Equivalent on 2021-08-25. Applicant: Medos International SARL. Device class: 2.

Clearance details

Applicant: Medos International SARL
Product code: Code KRA
Device class: Class 2
Regulation: 21 CFR 870.1210
Advisory panel: Cardiovascular
Date received: 2021-03-22
Decision date: 2021-08-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Le Locle, CH

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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.