APEX MEDICAL MOBINEB, 9R-027 SERIES— 510(k) K070990

Substantially Equivalent

Apex Medical Corp.

FDA 510(k) clearance K070990 for APEX MEDICAL MOBINEB, 9R-027 SERIES, Substantially Equivalent on 2007-05-18. Applicant: Apex Medical Corp..

Clearance details

Applicant: Apex Medical Corp.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2007-04-09
Decision date: 2007-05-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Taipei County, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.