Title 21

SECTION 868.5420

868.5420 Ether hook.

§ 868.5420 Ether hook.

(a) Identification. An ether hook is a device that fits inside a patient's mouth and that is intended to deliver vaporized ether.

(b) Classification. 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 system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38795, July 25, 2001]