Product Code: NHQ FDA class 2 21 CFR 868.1500

Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)

Anesthesiology

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.

510(k)s
0
FEI Numbers
50
Registration Numbers
50
Unique Applicants
0
Years Active

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

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.