K874495

Substantially Equivalent

ADCOMP 4000 HP SYSTEM

Applicant: Healthtek, Inc.
Product code: LHI
Advisory panel: General Hospital
Date received: 1987-11-02
Decision date: 1988-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nevada City, CA, US

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.