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AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K234134
510(k) Type
Traditional
Applicant
ResMed Pty Ltd (Registration Number: 3004604967)
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
9/24/2024
Days to Decision
270 days
Submission Type
Summary

AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K234134
510(k) Type
Traditional
Applicant
ResMed Pty Ltd (Registration Number: 3004604967)
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
9/24/2024
Days to Decision
270 days
Submission Type
Summary