SIMPLISCRIPTOR EK 31/101 037 16— 510(k) K832184

Substantially Equivalent

Litton Medical Electronics

FDA 510(k) clearance K832184 for SIMPLISCRIPTOR EK 31/101 037 16, Substantially Equivalent on 1983-10-31. Applicant: Litton Medical Electronics.

Clearance details

Applicant: Litton Medical Electronics
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1983-07-06
Decision date: 1983-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.