BTB · Hook, Ether
Anesthesiology · 21 CFR 868.5420 · Class 1
Overview
| Product Code | BTB |
|---|---|
| Device Name | Hook, Ether |
| Regulation | 21 CFR 868.5420 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
| GMP Exempt | Yes |
Identification
An ether hook is a device that fits inside a patient's mouth and that is intended to deliver vaporized ether.
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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Cleared Devices (0)
No cleared devices on record.
