DeviceClearance

AUTO DETECT FOR TELAHEART DR200/E-A— 510(k) K070014

Substantially Equivalent

North East Monitoring, Inc.

FDA 510(k) clearance K070014 for AUTO DETECT FOR TELAHEART DR200/E-A, Substantially Equivalent on 2007-05-25. Applicant: North East Monitoring, Inc.. Device class: 2.

Clearance details

Applicant
North East Monitoring, 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
Traditional
Location
Shelton, CT, US
Download summary PDFView on FDA.gov ↗

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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.