COMPRESSOR NEBULIZER MODEL MCN-S600XX— 510(k) K123030

Substantially Equivalent

Dongguan Aidisy Machinery & Electronic Equipment C

FDA 510(k) clearance K123030 for COMPRESSOR NEBULIZER MODEL MCN-S600XX, Substantially Equivalent on 2013-12-19. Applicant: Dongguan Aidisy Machinery & Electronic Equipment C.

Clearance details

Applicant: Dongguan Aidisy Machinery & Electronic Equipment C
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2012-09-28
Decision date: 2013-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dover, DE, US

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.