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S8 ASPEN WITH H4I PLUS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K091947
510(k) Type
Traditional
Applicant
RESMED LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/28/2009
Days to Decision
90 days
Submission Type
Summary

S8 ASPEN WITH H4I PLUS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K091947
510(k) Type
Traditional
Applicant
RESMED LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/28/2009
Days to Decision
90 days
Submission Type
Summary