KHA · Mask, Scavenging
Anesthesiology · 21 CFR 868.5590 · Class 1
Overview
| Product Code | KHA |
|---|---|
| Device Name | Mask, Scavenging |
| Regulation | 21 CFR 868.5590 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A scavenging mask is a device positioned over a patient's nose to deliver anesthetic or analgesic gases to the upper airway and to remove excess and exhaled gas. It is usually used during dentistry.
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.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K970046 | UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550) | Accutron, Inc. | Mar 28, 1997 | SESE |
Top Applicants
- Accutron, Inc. — 1 clearance
