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Luna CPAP and Auto CPAP System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153387
510(k) Type
Traditional
Applicant
3B MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/8/2016
Days to Decision
290 days
Submission Type
Summary

Luna CPAP and Auto CPAP System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153387
510(k) Type
Traditional
Applicant
3B MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/8/2016
Days to Decision
290 days
Submission Type
Summary