510(k) K922291— PERSONAL 120/210 LAPTOP STRESS OPTION

Substantially Equivalent

Biosound, Inc.

Clearance details

Applicant: Biosound, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1992-05-15
Decision date: 1992-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.