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MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180902
510(k) Type
Traditional
Applicant
MediPines Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/11/2019
Days to Decision
280 days
Submission Type
Summary

MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180902
510(k) Type
Traditional
Applicant
MediPines Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/11/2019
Days to Decision
280 days
Submission Type
Summary