Last synced on 1 July 2022 at 11:04 pm

Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192511
510(k) Type
Traditional
Applicant
Venner Medical (Singapore) PTE Ltd
Country
Singapore
FDA Decision
Substantially Equivalent
Decision Date
7/22/2020
Days to Decision
314 days
Submission Type
Summary

Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192511
510(k) Type
Traditional
Applicant
Venner Medical (Singapore) PTE Ltd
Country
Singapore
FDA Decision
Substantially Equivalent
Decision Date
7/22/2020
Days to Decision
314 days
Submission Type
Summary