Definition: A Isoflurane Gas Analyzer Is A Device Intended To Measure The Concentration Of Isoflurane Anesthetic In A Gas Mixture
Device Type ID | 161 |
Device Name | Analyzer, Gas, Isoflurane, Gaseous-phase (anesthetic Concentration) |
Regulation Description | Enflurane Gas Analyzer. |
Regulation Medical Specialty | Anesthesiology |
Review Panel | Anesthesiology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
Submission Type | 510(k) |
CFR Regulation Number | 868.1500 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | NHQ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
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Device Type ID | 161 |
Device | Analyzer, Gas, Isoflurane, Gaseous-phase (anesthetic Concentration) |
Product Code | NHQ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Enflurane Gas Analyzer. |
CFR Regulation Number | 868.1500 [🔎] |