I-PAD— 510(k) K062970

Name: FDA 510(k) clearance K062970
Creator: U.S. Food and Drug Administration
Published: 2008-01-22

Substantially Equivalent

Cu Medical Systems, Inc.

FDA 510(k) clearance K062970 for I-PAD, Substantially Equivalent on 2008-01-22. Applicant: Cu Medical Systems, Inc.. Device class: 3.

Clearance details

Applicant: Cu Medical Systems, Inc.
Product code: Code MKJ
Device class: Class 3
Regulation: 21 CFR 870.5310
Advisory panel: Cardiovascular
Date received: 2006-09-29
Decision date: 2008-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MKJ

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K143714 — Powerheart G5 AED2015-05-04
K150055 — OneStep Pediatric CPR Multi-Function Electrode2015-05-02
K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel2015-05-02
K142709 — samaritan PAD 450P2015-03-27
K133659 — HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING2015-01-23

Adverse events under product code MKJ

product code MKJ

Death: 961
Injury: 1,070
Malfunction: 90,719
Other: 8
Total: 92,758

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.