Omnispec ED1000— 510(k) K210166

Name: FDA 510(k) clearance K210166
Creator: U.S. Food and Drug Administration
Published: 2023-01-27

Substantially Equivalent

Medispec, Ltd.

FDA 510(k) clearance K210166 for Omnispec ED1000, Substantially Equivalent on 2023-01-27. Applicant: Medispec, Ltd.. Device class: 1.

Clearance details

Applicant: Medispec, Ltd.
Product code: Code ISA
Device class: Class 1
Regulation: 21 CFR 890.5660
Advisory panel: Physical Medicine
Date received: 2021-01-21
Decision date: 2023-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

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More clearances from Medispec, Ltd.

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K063504 — ECONOLITH EM10002007-03-09
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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.