CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.)— 510(k) K895446

Substantially Equivalent

Challenge Mfg., Inc.

FDA 510(k) clearance K895446 for CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.), Substantially Equivalent on 1989-11-27. Applicant: Challenge Mfg., Inc..

Clearance details

Applicant: Challenge Mfg., Inc.
Product code: Code HDB
Advisory panel: Obstetrics/Gynecology
Date received: 1989-09-08
Decision date: 1989-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bend, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HDB

product code HDB

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.