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510(k) Data Aggregation
K Number
K141152Device Name
ADVANTAGE
Manufacturer
STEVENSON INDUSTRIES, INC.
Date Cleared
2014-10-17
(165 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
STEVENSON INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Advantage TM is used with commercially available CPAPs to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA) for adults weighing more than 66 lb (30 Kg) used at home, hospital or other clinical settings per order of a physician.
Device Description
The CPAP/Pro Interface with Advantage ™ is available for upper and lower teeth. As such, it utilizes two typical "boil & bite" devices to be placed in patient's upper and lower dental arches. They are then affixed to one another anteriorly to limit the mouth opening, while still permitting a degree of mouth opening through spacers and resiliency. The upper member is slotted and slides forward and backward on a fixed post for patient comfort. Additionally, it allows lateral movement with the post as a pivot point. The CPAP/Pro Interface with Advantage TM, similar to chin straps or mouth tapes, minimizes the mouth breathing but provides comfort and ease of use for patients. The device is used for adult patients at home or clinical facilities, such as hospitals or sleep labs.
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K Number
K992384Device Name
CPAP/PRO CPAP INTERFACE
Manufacturer
STEVENSON INDUSTRIES, INC.
Date Cleared
1999-12-01
(138 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
STEVENSON INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CPAP/PRO® CPAP Interface is intended to treat adult obstructive sleep apnea(OSA).
Device Description
The CPAP/PRO® CPAP Interface consists of a boil & bite type dental appliance or a bracket, which may be professionally fitted to a custom dental appliance. With either mouth appliance, a small bracket extends beyond the lips to attach to a pair of corrugated nasal tubes. The paired nasal tubes are made from corrugated polyethylene and are pressure tested. The paired tubes combine to form a "Y", The lower arm of which attaches to a CPAP machine using a fitting connected to standard respirator tubing. The upper arms of the "Y" shaped nasel tubes terminate in soft silicone nasal inserts. The inserts provide a soft, comfortable seal against the nostrils.
The CPAP/PRO® consists of the following major components:
1. Boil & bite molded dental appliance with integral tubing clamp.
2. CPAP/PRO® tubing clamp for use with professionally fitted dental appliance.
3. Polycarbonate dual lumen respiratory tubing connector.
4. Corrugated 15mm (nominal diameter) polyethylene tubing with 1/8m " vent holes.
5. Silicone elastomer nasal inserts.
6. Dual lumen (polycarbonate) tubing/appliance bracket .
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