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510(k) Data Aggregation
K Number
K022934Device Name
SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650
Date Cleared
2002-11-14
(71 days)
Product Code
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
GOTTLIEB WEINMANN GERAETE FUER MEDIZIN UND ARBEITS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Weinmann Silentflow 2 Exhalation System is intended for prescription use to be used with nasal masks which are used in CPAP or bi-level pressure therapy for adult patients (> 30 kg) and do not have a built-in exhalation device.
Device Description
The Weinmann Silentflow 2 Exhalation System consists of two components assembled together. It allows for a patient to exhale during CPAP or bi-level pressure therapy.
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K Number
K013738Device Name
WEINMANN SOMNOMASK
Date Cleared
2002-01-22
(70 days)
Product Code
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
GOTTLIEB WEINMANN GERAETE FUER MEDIZIN UND ARBEITS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Weinmann SOMNOmask is intended for prescription use to be used during nasal CPAP or Bi-level Positive Pressure therapy for adult patients (>30 KG).
Device Description
The Weinmann SOMNOmask comes in three sizes, small, medium and large. It has a removable mask seal. Because the Weinmann SOMNOmask does not contain any ports or vents for removing the CO2 buildup, an external exhalation device must be used. The SOMNOmask is secured to the patient's head with a 4-point headgear called the SOMNOstrap.
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