FDA 510(k)

RAE(R) II TRACHEAL TUBE

K-Number: K932280 · 1993-07-08

Decision Date1993-07-08

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

RAE(R) II TRACHEAL TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Medical. It received FDA 510(k) clearance on 1993-07-08 under 510(k) number K932280. 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 RAE(R) II TRACHEAL TUBE?

RAE(R) II TRACHEAL TUBE is a medical device that received FDA 510(k) clearance on 1993-07-08. The listed applicant is Mallinckrodt Medical. The 510(k) number is K932280.

When did RAE(R) II TRACHEAL TUBE receive FDA 510(k) clearance?

RAE(R) II TRACHEAL TUBE received FDA 510(k) clearance on 1993-07-08, under 510(k) number K932280.

Who is the listed applicant for RAE(R) II TRACHEAL TUBE?

The FDA 510(k) record lists Mallinckrodt Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAE(R) II TRACHEAL TUBE?

The FDA product code for RAE(R) II TRACHEAL TUBE is BTR.

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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.