Venner Tracheal Seal Monitor
FDA 510(k) K110631 · Venner Medical (Singapore) Pte, Ltd.
510(k) numberK110631
Submission
- Device name
- Venner Tracheal Seal Monitor
- Applicant
- Venner Medical (Singapore) Pte, Ltd.
Rockville, MD, US - Received
- March 4, 2011
- Decision date
- July 28, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BSK – Cuff, Tracheal Tube, Inflatable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5750
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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More from Hospitech Respiration , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K192511 | Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube)…BTO · Traditional | 07/22/2020SE |
| K192120 | Venner PneuX ETT (Endotracheal Tube) 6 mm, Venner PneuX ETT (Endotracheal Tube) 7 mm…BTR · Traditional | 02/14/2020SE |
| K191602 | APA Oxy BladeCCW · Traditional | 08/02/2019SE |
| K100950 | Venner Pneux P.Y. (TM) Tracheostomy TubeBTO · Traditional | 07/13/2010SE |
| K093135 | Venner Pneux P.Y. (TM) Tracheostomy Tube and Endo Tracheal TubeBTR · Traditional | 04/02/2010SE |
Questions and answers
When was Venner Tracheal Seal Monitor cleared by the FDA?
Venner Tracheal Seal Monitor (K110631) received a 510(k) decision of Substantially Equivalent on July 28, 2011, 146 days after the submission was received.
What is the product code of K110631?
The FDA product code is BSK – Cuff, Tracheal Tube, Inflatable, a Class II (moderate risk) device regulated under 21 CFR 868.5750.