VENNER TRACHEAL SEAL MONITOR— 510(k) K110631
Substantially EquivalentVenner Medical (Singapore) Pte, Ltd.
FDA 510(k) clearance K110631 for VENNER TRACHEAL SEAL MONITOR, Substantially Equivalent on 2011-07-28. Applicant: Venner Medical (Singapore) Pte, Ltd.. Device class: 2.
Clearance details
- Applicant
- Venner Medical (Singapore) Pte, Ltd.
- Product code
- Code BSK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5750
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockville, MD, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.