REKA E100— 510(k) K111438

Substantially Equivalent

Reka Pte, Ltd.

FDA 510(k) clearance K111438 for REKA E100, Substantially Equivalent on 2011-09-12. Applicant: Reka Pte, Ltd..

Clearance details

Applicant: Reka Pte, Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2011-05-24
Decision date: 2011-09-12
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Summerville, SC, US

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.