LogoFDA 510(k) Search
K Number
K991972
Device Name
INFANT FLOW SYSTEM
Manufacturer
SENSORMEDICS CORP.
Date Cleared
1999-08-13

(63 days)

Product Code
BZD
Regulation Number
868.5905
Type
Special
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SensorMedics Infant Flow System, consisting of a Driver and NCPAP Prongs, is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.

Device Description

Infant Flow System, consisting of a Driver and NCPAP Prongs

AI/ML Overview

I am sorry, but the provided text does not contain the information requested in the prompt. The document is a 510(k) clearance letter from the FDA for the "Infant Flow System" and an "Indications for Use" statement. It does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).