Search Results
Found 2 results
510(k) Data Aggregation
K Number
K221676Device Name
Exsalta
Manufacturer
Date Cleared
2022-09-16
(99 days)
Product Code
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
DRW Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended to be used in a medical facility as a means to help evacuate saliva, mucous, vomit or other aspirant from the mouth and/or airway to allow adequate respiration or ventilation of the patient
Device Description
Exsalta is an AC 110 V powered microprocessor controlled peristaltic suction pump used for clearance of airway secretions. The device is used on a desktop, or shelf. This peristaltic suction pump with touch screen controls is designed for suction procedures where low airflow is desired. Exsalta (the pump) is a reusable device. The accessories are single use.
Ask a Question
Ask a specific question about this device
K Number
K172284Device Name
NAPA LP-15 Airway Pressure Monitor
Manufacturer
Date Cleared
2018-02-09
(196 days)
Product Code
Regulation Number
868.2600Why did this record match?
Applicant Name (Manufacturer) :
DRW Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NAPA LP-15 Airway Pressure Monitor is intended to measure and monitor airway pressure for neonatal patients being treated with positive pressure therapy, including neonatal Continuous Positive Airway Pressure (CPAP) devices (e.g. Bubble CPAP). The device provides audible and visual alarms when the airway pressure falls outside of the user selected high and low alarm limits. The device is intended to be pole mounted for stationary use in hospitals only. For professional use only.
Device Description
The NAPA LP-15 Airway Pressure Monitor is a compact mains operated monitoring device that continuously monitors and displays the neonatal patient's average airway treatment pressure during neonatal CPAP therapy (e.g. Bubble CPAP) and provides high and low alarms for pressures that exceed set limits.
Ask a Question
Ask a specific question about this device
Page 1 of 1