X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764ID— 510(k) K982824

Name: FDA 510(k) clearance K982824
Creator: U.S. Food and Drug Administration
Published: 1998-10-29

Substantially Equivalent

I.E.D., Inc.

FDA 510(k) clearance K982824 for X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764ID, Substantially Equivalent on 1998-10-29. Applicant: I.E.D., Inc.. Device class: 2.

Clearance details

Applicant: I.E.D., Inc.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 1998-08-11
Decision date: 1998-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Islandia, NY, US

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.