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BAROnova Insufflation System, BAROnova Accessory Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190985
510(k) Type
Traditional
Applicant
BAROnova, Inc.
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
5/14/2019
Days to Decision
29 days
Submission Type
Summary

BAROnova Insufflation System, BAROnova Accessory Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190985
510(k) Type
Traditional
Applicant
BAROnova, Inc.
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
5/14/2019
Days to Decision
29 days
Submission Type
Summary