12 LEAD GLOVE— 510(k) K100315

Substantially Equivalent

I Needmd, Inc.

FDA 510(k) clearance K100315 for 12 LEAD GLOVE, Substantially Equivalent on 2010-04-23. Applicant: I Needmd, Inc..

Clearance details

Applicant: I Needmd, Inc.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 2010-02-04
Decision date: 2010-04-23
Decision: Substantially Equivalent
Clearance type: Special
Location: New York, NY, US

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Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.