VIDEO ENHANCEMENT UNIT— 510(k) K954222

Name: FDA 510(k) clearance K954222
Creator: U.S. Food and Drug Administration
Published: 1995-12-08

Substantially Equivalent

Perkins Mfg. Co.

FDA 510(k) clearance K954222 for VIDEO ENHANCEMENT UNIT, Substantially Equivalent on 1995-12-08. Applicant: Perkins Mfg. Co.. Device class: 2.

Clearance details

Applicant: Perkins Mfg. Co.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1995-09-11
Decision date: 1995-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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K920550 — DISPLAY PROCESSOR - MODEL IDP51001992-04-13
K915232 — GRUNDIG ELECTRONICS VARIOUS MODELS1992-01-09
K910384 — VIDEO ANNOTATOR MODEL PK23101991-04-16

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.