Statements (65)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
medical device classification
|
| gptkbp:example |
hearing aids
endoscopes condoms pulse oximeters blood glucose meters infusion pumps powered wheelchairs surgical scissors dental impression materials patient lifts ultrasound imaging systems surgical gloves contact lens care products surgical forceps surgical staplers automated external defibrillators electrosurgical devices dental handpieces dental amalgam electrocardiographs IV catheters blood pressure cuffs bone growth stimulators bone plates dental curing lights dental x-ray machines external bone fixation systems fetal monitors glucose test systems infant incubators infusion sets orthopedic screws powered breast pumps pregnancy test kits surgical cannulas surgical chisels surgical clamps surgical curettes surgical dilators surgical drapes surgical drills surgical elevators surgical gouges surgical hooks surgical lasers surgical mallets surgical mesh surgical needles surgical probes surgical rasps surgical retractors surgical saws surgical speculums surgical suction pumps surgical trocars syringe pumps urinary catheters |
| https://www.w3.org/2000/01/rdf-schema#label |
Class II medical device
|
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:requires |
general controls
special controls |
| gptkbp:riskFactor |
moderate risk
|
| gptkbp:bfsParent |
gptkb:Class_II
|
| gptkbp:bfsLayer |
4
|