Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
The Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) (product code NHQ) is an anesthesiology monitoring device that measures the concentration of isoflurane anesthetic gas in the breathing circuit to guide appropriate dosing and monitor anesthetic delivery, 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
- NHQ
- Device Class
- FDA class 2
- Regulation Number
- 868.1500
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
Definition
A isoflurane gas analyzer is a device intended to measure the concentration of isoflurane anesthetic in a gas mixture
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.