CPR PLUS— 510(k) K926333

Substantially Equivalent

Kells Medical, Inc.

FDA 510(k) clearance K926333 for CPR PLUS, Substantially Equivalent on 1993-11-08. Applicant: Kells Medical, Inc..

Clearance details

Applicant: Kells Medical, Inc.
Product code: Code LIX
Advisory panel: Cardiovascular
Date received: 1992-12-16
Decision date: 1993-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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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.