ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603— 510(k) K100266

Name: FDA 510(k) clearance K100266
Creator: U.S. Food and Drug Administration
Published: 2010-04-29

Substantially Equivalent

Camntech, Ltd.

FDA 510(k) clearance K100266 for ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603, Substantially Equivalent on 2010-04-29. Applicant: Camntech, Ltd.. Device class: 2.

Clearance details

Applicant: Camntech, Ltd.
Product code: Code MWJ
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2010-01-29
Decision date: 2010-04-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Papworth Everard, Cambridgeshire, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

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.