TUBE HOUSING ASSEMBLIES— 510(k) K912338

Substantially Equivalent

Comet Ltd. C/O Radiology Resources, Inc.

FDA 510(k) clearance K912338 for TUBE HOUSING ASSEMBLIES, Substantially Equivalent on 1991-08-07. Applicant: Comet Ltd. C/O Radiology Resources, Inc..

Clearance details

Applicant: Comet Ltd. C/O Radiology Resources, Inc.
Product code: Code ITY
Advisory panel: Radiology
Date received: 1991-05-24
Decision date: 1991-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Switzerland, CH

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Adverse events under product code ITY

product code ITY

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.