Filter, Conduction, Anesthetic

Device Code: 9

Product Code(s): BSN

Device Classification Information

Device Type ID9
Device NameFilter, Conduction, Anesthetic
Regulation DescriptionAnesthesia Conduction Filter.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type510(k)
CFR Regulation Number868.5130 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeBSN
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID9
DeviceFilter, Conduction, Anesthetic
Product CodeBSN
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAnesthesia Conduction Filter.
CFR Regulation Number868.5130 [🔎]
Premarket Reviews
ManufacturerDecision
EMD MILLIPORE CORPORATION
 
SUBSTANTIALLY EQUIVALENT
1
TPLC Last Update: 2019-04-02 19:26:22

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