PXA · Oral Administration Set
General Hospital · 21 CFR 880.6430 · Class 1
Overview
| Product Code | PXA |
|---|---|
| Device Name | Oral Administration Set |
| Regulation | 21 CFR 880.6430 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication.
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 § 880.9. 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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
