Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
The Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) (product code NHP) is an anesthesiology monitoring device that measures the concentration of sevoflurane anesthetic gas during administration to help maintain appropriate anesthetic depth, as described in its definition. It is classified as an FDA Class 2 device within the Anesthesiology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- NHP
- Device Class
- FDA class 2
- Regulation Number
- 868.1500
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
Definition
A sevoflurane gas analyzer is a device intended to measure the concentration of sevoflurane anesthetic in a gas mixture
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 |
|---|---|---|---|---|
| K040188 | INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE | Apr 14, 2004 | Substantially Equivalent | Draeger Medical Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 50 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 50 registration numbers. Click on an entry to view related FDA registrations.