MOD

14 FDA 510(k) clearances · Product code

FDA profile

Official device name

Accessory To Continuous Ventilator (Respirator)

Device class

Class II (moderate risk)

Regulation

21 CFR 868.5895

Medical specialty

Anesthesiology

Flags

Third-party review eligible

Adverse events (MAUDE)

1996: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free