DIGITAL PANEL METER— 510(k) K781255

Substantially Equivalent

Rae Medical Corp.

FDA 510(k) clearance K781255 for DIGITAL PANEL METER, Substantially Equivalent on 1978-09-20. Applicant: Rae Medical Corp..

Clearance details

Applicant: Rae Medical Corp.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1978-07-21
Decision date: 1978-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.