Search Results
Found 1 results
510(k) Data Aggregation
K Number
K111587Device Name
ALERKAN SPIROMETRY FILTER
Manufacturer
ALERKAN LTD
Date Cleared
2011-10-20
(135 days)
Product Code
BZG
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
ALERKAN LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use with pulmonary function testing (PFT) equipment only. To filter air between the patient's exhaled air and the testing equipment. Single patient use, single session, and disposable. Maximum duration of use is 24 hrs.
Device Description
Not Found
Ask a Question
Page 1 of 1