510(k) K941319— THE WUSCOPE SYSTEM

Substantially Equivalent

Achi Corp.

Clearance details

Applicant: Achi Corp.
Product code: Code CCW
Advisory panel: Anesthesiology
Date received: 1994-03-18
Decision date: 1994-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Adverse events under product code CCW

product code CCW

Death: 31
Injury: 136
Malfunction: 3,703
Other: 1
Total: 3,871

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.