Mask, Scavenging
Scavenging Mask is an anesthesiology device placed over the patient's nose and mouth that captures exhaled anesthetic gases and waste gas vapors, routing them to a scavenging system to prevent occupational exposure of operating room personnel to anesthetic agents. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KHA, regulated under 21 CFR 868.5590, within the Anesthesiology medical specialty.
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Basic Information
- Product Code
- KHA
- Device Class
- FDA class 1
- Regulation Number
- 868.5590
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K970046 | UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550) | Mar 28, 1997 | Substantially Equivalent | Accutron, Inc. |
FEI Numbers
This FDA classification entry is associated with 195 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 195 registration numbers. Click on an entry to view related FDA registrations.