510(k) K210166— Omnispec ED1000

Substantially Equivalent

Medispec, Ltd.

Clearance details

Applicant: Medispec, Ltd.
Product code: Code ISA
Advisory panel: Physical Medicine
Date received: 2021-01-21
Decision date: 2023-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Adverse events under product code ISA

product code ISA

Death: 3
Other: 1
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.