FDA 510(k)

LMA FASTRACH ETT SINGLE USE

K-Number: K051993 · 2005-12-13

Decision Date2005-12-13

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

LMA FASTRACH ETT SINGLE USE is the device name listed in this FDA 510(k) record. The listed applicant is The Laryngeal Mask Co., Ltd.. It received FDA 510(k) clearance on 2005-12-13 under 510(k) number K051993. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LMA FASTRACH ETT SINGLE USE?

LMA FASTRACH ETT SINGLE USE is a medical device that received FDA 510(k) clearance on 2005-12-13. The listed applicant is The Laryngeal Mask Co., Ltd.. The 510(k) number is K051993.

When did LMA FASTRACH ETT SINGLE USE receive FDA 510(k) clearance?

LMA FASTRACH ETT SINGLE USE received FDA 510(k) clearance on 2005-12-13, under 510(k) number K051993.

Who is the listed applicant for LMA FASTRACH ETT SINGLE USE?

The FDA 510(k) record lists The Laryngeal Mask Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LMA FASTRACH ETT SINGLE USE?

The FDA product code for LMA FASTRACH ETT SINGLE USE is BTR.

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Other records listing The Laryngeal Mask Co., Ltd. as applicant

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Related Devices (Code: BTR)

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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.