DeviceClearance

MH1 MICROHOLTER RECORDER— 510(k) K101969

Substantially Equivalent

Exelys, LLC

FDA 510(k) clearance K101969 for MH1 MICROHOLTER RECORDER, Substantially Equivalent on 2011-02-04. Applicant: Exelys, LLC. Device class: 2.

Clearance details

Applicant
Exelys, LLC
Product code
Code MWJ
Device class
Class 2
Regulation
21 CFR 870.2800
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Austin, TX, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code MWJ

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Adverse events under product code MWJ

product code MWJ
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.