B&B BUBBLER

• K Number: K133210
• Device Name: B&B BUBBLER
• Manufacturer: S & T MEDICAL TECHNOLOGIES, INC.
• Date Cleared: 2014-03-28 ( 162 days)
• Product Code: BYE
• Regulation Number: 868.5965
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

The B&B Bubbler is intended to provide CPAP, in a hospital environment, to spontaneously breathing neonates and infants

Device Description

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Regulation Number and Section

§ 868.5965 Positive end expiratory pressure breathing attachment.

(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).