BATTERY PACK# S1009LA— 510(k) K933065

Substantially Equivalent

Portable Power Systems, Inc.

FDA 510(k) clearance K933065 for BATTERY PACK# S1009LA, Substantially Equivalent on 1994-02-17. Applicant: Portable Power Systems, Inc..

Clearance details

Applicant
Portable Power Systems, Inc.
Product code
Code DPS
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Castle Rock, CO, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DPS

product code DPS
Death
7
Total
7

Source: openFDA MAUDE database, through . 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.