BATTERY PACK #PMX120-18A— 510(k) K945043

Name: FDA 510(k) clearance K945043
Creator: U.S. Food and Drug Administration
Published: 1995-01-20

Substantially Equivalent

Portable Power Systems, Inc.

FDA 510(k) clearance K945043 for BATTERY PACK #PMX120-18A, Substantially Equivalent on 1995-01-20. Applicant: Portable Power Systems, Inc.. Device class: 2.

Clearance details

Applicant: Portable Power Systems, Inc.
Product code: Code IZL
Device class: Class 2
Regulation: 21 CFR 892.1720
Advisory panel: Radiology
Date received: 1994-10-14
Decision date: 1995-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castle Rock, CO, US

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.