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IQSense Flow Sensor Mouthpiece

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150515
510(k) Type
Traditional
Applicant
SDI DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/12/2016
Days to Decision
316 days
Submission Type
Statement

IQSense Flow Sensor Mouthpiece

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150515
510(k) Type
Traditional
Applicant
SDI DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/12/2016
Days to Decision
316 days
Submission Type
Statement