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510(k) Data Aggregation
K Number
K042294Device Name
SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007)
Manufacturer
Date Cleared
2004-09-10
(17 days)
Product Code
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
SUITER ENTERPRISES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SLUMBERGEAR™ headgear is an accessory to a non-continuous ventilator (respirator), intended for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic, and/or home environments. The headgear is reusable and for single-patient use.
Device Description
SLUMBERGEAR™ is a one-piece headgear with an integrated chinstrap used to secure externally placed masks, nasal pillows, and cannulas to the face of the patient, The headgear is a single strap that splits to wrap around the chin, the back of the head, and the top portions of the patient's head. Velcro® attached to each split portion of the headgear strap is used to fasten the headgear to the required respiratory device.
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