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K Number
K954525
Device Name
SENSI-TOUCH EPIDURAL ANESTHESIA FILTER
Manufacturer
SHERWOOD MEDICAL CO.
Date Cleared
1996-01-19

(112 days)

Product Code
BXN
Regulation Number
868.2775
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.2775 Electrical peripheral nerve stimulator.

(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).