Device Type ID | 9 |
Device Name | Filter, Conduction, Anesthetic |
Regulation Description | Anesthesia Conduction Filter. |
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 | 868.5130 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | BSN |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 9 |
Device | Filter, Conduction, Anesthetic |
Product Code | BSN |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Anesthesia Conduction Filter. |
CFR Regulation Number | 868.5130 [🔎] |
Premarket Reviews | ||
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Manufacturer | Decision | |
EMD MILLIPORE CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 |