ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO— 510(k) K071025

Name: FDA 510(k) clearance K071025
Creator: U.S. Food and Drug Administration
Published: 2007-06-22

Substantially Equivalent

Zoll Medical Corporation, World Wide Headquarters

FDA 510(k) clearance K071025 for ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO, Substantially Equivalent on 2007-06-22. Applicant: Zoll Medical Corporation, World Wide Headquarters. Device class: 3.

Clearance details

Applicant: Zoll Medical Corporation, World Wide Headquarters
Product code: Code MKJ
Device class: Class 3
Regulation: 21 CFR 870.5310
Advisory panel: Cardiovascular
Date received: 2007-04-11
Decision date: 2007-06-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Chelsmford, MA, US

Download summary PDF View on FDA.gov ↗

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K142709 — samaritan PAD 450P2015-03-27
K133659 — HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING2015-01-23

More clearances from Zoll Medical Corporation, World Wide Headquarters

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K133239 — ZOLL E SERIES2015-01-16
K133269 — ZOLL X SERIES2014-05-22
K120406 — ZOLL FULLY AUTOMATIC AED PLUS2012-10-26
K120907 — ZOLL R SERIES2012-09-25
K112761 — ZOLL PROPAQ MD2012-04-25

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.