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IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K131901
510(k) Type
Traditional
Applicant
3B MEDICAL, INC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/23/2013
Days to Decision
181 days
Submission Type
Summary

IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K131901
510(k) Type
Traditional
Applicant
3B MEDICAL, INC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/23/2013
Days to Decision
181 days
Submission Type
Summary