21 CFR 878.5070 — Unit, Airflow, Laminar
General, Plastic Surgery (SU) · Part 878 Subpart F—Therapeutic Devices · § 878.5070
Identification
Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.
Classification Rationale
Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FLJ | Unit, Airflow, Laminar | 2 | 0 | 3rd Party |
| FRT | Unit, Isolation, Surgical | 2 | 0 | 3rd Party |
| FYD | Apparatus, Exhaust, Surgical | 2 | 75 | 3rd Party |
| FZG | Apparatus, Air Handling, Bench | 2 | 1 | |
| FZH | Apparatus, Air Handling, Room | 2 | 4 | |
| FZI | Apparatus, Air Handling, Enclosure | 2 | 5 | |
| ORC | Air Filter Portable Apparatus | 2 | 6 | 3rd Party |
Special Controls
FLJ — Unit, Airflow, Laminar
*Classification.* Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
eCFR
FRT — Unit, Isolation, Surgical
*Classification.* Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
eCFR
FYD — Apparatus, Exhaust, Surgical
*Classification.* Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
eCFR
FZG — Apparatus, Air Handling, Bench
*Classification.* Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
eCFR
FZH — Apparatus, Air Handling, Room
*Classification.* Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
eCFR
FZI — Apparatus, Air Handling, Enclosure
*Classification.* Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
eCFR
ORC — Air Filter Portable Apparatus
*Classification.* Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
eCFR
