ORC

Air Filter Portable Apparatus

Product code

ORC

Device name

Air Filter Portable Apparatus

Device class

Class 2

21 CFR

21 CFR 878.5070

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

6 (all years; only the last 3 years are listed here)

FDA classification definition

The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.

Definition text from the FDA device classification database (U.S. federal government work, public domain).