CPR BAND— 510(k) K201581

Substantially Equivalent

Credo

FDA 510(k) clearance K201581 for CPR BAND, Substantially Equivalent on 2021-03-06. Applicant: Credo.

Clearance details

Applicant: Credo
Product code: Code LIX
Advisory panel: Cardiovascular
Date received: 2020-06-11
Decision date: 2021-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wonju-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code LIX

product code LIX

Other: 2
Total: 2

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.