MINISCOPE MS-2— 510(k) K830411

Substantially Equivalent

Jedmed Instrument Co.

FDA 510(k) clearance K830411 for MINISCOPE MS-2, Substantially Equivalent on 1983-04-27. Applicant: Jedmed Instrument Co..

Clearance details

Applicant: Jedmed Instrument Co.
Product code: Code DSP
Advisory panel: Cardiovascular
Date received: 1983-02-08
Decision date: 1983-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DSP

product code DSP

Death: 317
Injury: 566
Malfunction: 36,831
Other: 4
Total: 37,718

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.