DIAMED MODELS 600, 900, 960, 964— 510(k) K854953

Substantially Equivalent

Diamed Division Ill. Tool Works, Inc.

FDA 510(k) clearance K854953 for DIAMED MODELS 600, 900, 960, 964, Substantially Equivalent on 1986-04-22. Applicant: Diamed Division Ill. Tool Works, Inc..

Clearance details

Applicant: Diamed Division Ill. Tool Works, Inc.
Product code: Code JAA
Advisory panel: Radiology
Date received: 1985-12-10
Decision date: 1986-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Hills, CA, US

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Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.