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FDA 510(k)

VENNER TRACHEAL SEAL MONITOR

K-Number: K110631 · 2011-07-28

ApplicantVenner Medical (Singapore) Pte, Ltd.
Decision Date2011-07-28
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VENNER TRACHEAL SEAL MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Venner Medical (Singapore) Pte, Ltd.. It received FDA 510(k) clearance on 2011-07-28 under 510(k) number K110631. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENNER TRACHEAL SEAL MONITOR?

VENNER TRACHEAL SEAL MONITOR is a medical device that received FDA 510(k) clearance on 2011-07-28. The listed applicant is Venner Medical (Singapore) Pte, Ltd.. The 510(k) number is K110631.

When did VENNER TRACHEAL SEAL MONITOR receive FDA 510(k) clearance?

VENNER TRACHEAL SEAL MONITOR received FDA 510(k) clearance on 2011-07-28, under 510(k) number K110631.

Who is the listed applicant for VENNER TRACHEAL SEAL MONITOR?

The FDA 510(k) record lists Venner Medical (Singapore) Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENNER TRACHEAL SEAL MONITOR?

The FDA product code for VENNER TRACHEAL SEAL MONITOR is BSK.

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Other records listing Venner Medical (Singapore) Pte, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192511Venner 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 mmK192120Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mmK191602APA Oxy BladeK100950VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBEK093135VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE

Related Devices (Code: BSK)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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