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510(k) Data Aggregation
K Number
K962872Device Name
RESPIFLO
Manufacturer
Date Cleared
1997-02-25
(217 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
TYCO HEALTHCARE DEUTSCHALAND GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For Inhalation and Humidification by way of Sterile Water in a closed system during Inhalation Therapy.
Device Description
This product is Sterile Water for Inhalation Therapy. It is packaged in a closed system and it is disposable after one use. The water is sterile and endotoxin free according to the USP. The product is used for Inhalation and Humidification during Inhalation Therapy.
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