CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.)— 510(k) K881967

Substantially Equivalent

Challenge Mfg., Inc.

FDA 510(k) clearance K881967 for CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.), Substantially Equivalent on 1988-06-13. Applicant: Challenge Mfg., Inc..

Clearance details

Applicant: Challenge Mfg., Inc.
Product code: Code HDB
Advisory panel: Obstetrics/Gynecology
Date received: 1988-05-11
Decision date: 1988-06-13
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.