OFP · Anesthesia Breathing Circuit Kit (Adult & Pediatric)
Anesthesiology · 21 CFR 868.5240 · Class 1
Overview
| Product Code | OFP |
|---|---|
| Device Name | Anesthesia Breathing Circuit Kit (Adult & Pediatric) |
| Regulation | 21 CFR 868.5240 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
