DeviceClearance

RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100— 510(k) K032882

Substantially Equivalent

Recom Managed Systems, Inc.

FDA 510(k) clearance K032882 for RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100, Substantially Equivalent on 2004-01-28. Applicant: Recom Managed Systems, Inc.. Device class: 2.

Clearance details

Applicant
Recom Managed Systems, Inc.
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
Abbreviated
Location
Valley Village, CA, 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.