FDA 510(k)

FIRE STICK

K-Number: K973197 · 1998-02-27

Decision Date1998-02-27

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

FIRE STICK is the device name listed in this FDA 510(k) record. The listed applicant is H.S. Intl. Co., Inc.. It received FDA 510(k) clearance on 1998-02-27 under 510(k) number K973197. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIRE STICK?

FIRE STICK is a medical device that received FDA 510(k) clearance on 1998-02-27. The listed applicant is H.S. Intl. Co., Inc.. The 510(k) number is K973197.

When did FIRE STICK receive FDA 510(k) clearance?

FIRE STICK received FDA 510(k) clearance on 1998-02-27, under 510(k) number K973197.

Who is the listed applicant for FIRE STICK?

The FDA 510(k) record lists H.S. Intl. Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIRE STICK?

The FDA product code for FIRE STICK is GEI.

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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.