DXP1000 HOLTER RECORDER— 510(k) K993618

Name: FDA 510(k) clearance K993618
Creator: U.S. Food and Drug Administration
Published: 1999-11-24

Substantially Equivalent

Braemar Corp.

FDA 510(k) clearance K993618 for DXP1000 HOLTER RECORDER, Substantially Equivalent on 1999-11-24. Applicant: Braemar Corp.. Device class: 2.

Clearance details

Applicant: Braemar Corp.
Product code: Code MWJ
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 1999-10-26
Decision date: 1999-11-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Burnsville, MN, US

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.