PB-A LEAD-ACID BATTERY CONVERSION KIT— 510(k) K875106

Name: FDA 510(k) clearance K875106
Creator: U.S. Food and Drug Administration
Published: 1988-02-22

Substantially Equivalent

Diagnostic Imaging Specialists Corp.

FDA 510(k) clearance K875106 for PB-A LEAD-ACID BATTERY CONVERSION KIT, Substantially Equivalent on 1988-02-22. Applicant: Diagnostic Imaging Specialists Corp.. Device class: 2.

Clearance details

Applicant: Diagnostic Imaging Specialists Corp.
Product code: Code IZL
Device class: Class 2
Regulation: 21 CFR 892.1720
Advisory panel: Radiology
Date received: 1987-12-14
Decision date: 1988-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Malo, Manitoba, CA

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.