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F&P Eson 2 Nasal Mask

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153505
510(k) Type
Traditional
Applicant
FISHER & PAYKEL HEALTHCARE LIMITED
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
9/20/2016
Days to Decision
288 days
Submission Type
Summary

F&P Eson 2 Nasal Mask

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153505
510(k) Type
Traditional
Applicant
FISHER & PAYKEL HEALTHCARE LIMITED
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
9/20/2016
Days to Decision
288 days
Submission Type
Summary