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AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233555
510(k) Type
Traditional
Applicant
Philips Respironics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/31/2024
Days to Decision
268 days
Submission Type
Summary

AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233555
510(k) Type
Traditional
Applicant
Philips Respironics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/31/2024
Days to Decision
268 days
Submission Type
Summary