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AF541 SE Full Face Mask

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150638
510(k) Type
Abbreviated
Applicant
Respironics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/18/2015
Days to Decision
191 days
Submission Type
Summary

AF541 SE Full Face Mask

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150638
510(k) Type
Abbreviated
Applicant
Respironics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/18/2015
Days to Decision
191 days
Submission Type
Summary