21 CFR 868.6225 — Clip, Nose
Anesthesiology (AN) · Part 868 Subpart G—Miscellaneous · § 868.6225
Identification
A nose clip is a device intended to close a patient's external nares (nostrils) during diagnostic or therapeutic procedures.
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. The device is also 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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BXJ | Clip, Nose | 1 | 4 |
