REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S— 510(k) K931484

Substantially Equivalent

Portable Power Systems, Inc.

FDA 510(k) clearance K931484 for REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S, Substantially Equivalent on 1994-02-17. Applicant: Portable Power Systems, Inc..

Clearance details

Applicant: Portable Power Systems, Inc.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 1993-03-24
Decision date: 1994-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castle Rock, CO, US

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Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.