FDA 510(k) clearance · back to tracker

CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel

Bio-Detek, Inc. cleared K150198 on 2015-05-02, decision: substantially equivalent

K-number

K150198

Sponsor

Bio-Detek, Inc.

Device

CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel

Class

Class III

Decision

Substantially Equivalent

Decision date

2015-05-02

Product code

MKJ

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.5310

Official FDA record

Open K150198on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.