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FDA 510(k)

PROXENON 350, MODEL 902XX

K-Number: K071218 · 2007-06-14

ApplicantWelch Allyn, Inc.
Decision Date2007-06-14
Product CodeFST
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROXENON 350, MODEL 902XX is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 2007-06-14 under 510(k) number K071218. The device is classified under product code FST. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROXENON 350, MODEL 902XX?

PROXENON 350, MODEL 902XX is a medical device that received FDA 510(k) clearance on 2007-06-14. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K071218.

When did PROXENON 350, MODEL 902XX receive FDA 510(k) clearance?

PROXENON 350, MODEL 902XX received FDA 510(k) clearance on 2007-06-14, under 510(k) number K071218.

Who is the listed applicant for PROXENON 350, MODEL 902XX?

The FDA 510(k) record lists Welch Allyn, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROXENON 350, MODEL 902XX?

The FDA product code for PROXENON 350, MODEL 902XX is FST.

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Official Source

View on FDA Database →

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

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