← FDA Medical Device Classifications
Air Filter Portable Apparatus
ORC · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.5070
Classification
- FDA Product Code
ORC- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 878.5070
- Review panel
- HO
- Medical specialty
- General, Plastic Surgery
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.
Market data
- Cleared 510(k) submissions
- 6
- Registered establishments
- 2
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown