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FDA 510(k)

HOME-AWAY SYSTEM, MODEL 1041

K-Number: K042944 · 2005-04-15

ApplicantIn-X Corporation
Decision Date2005-04-15
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HOME-AWAY SYSTEM, MODEL 1041 is the device name listed in this FDA 510(k) record. The listed applicant is In-X Corporation. It received FDA 510(k) clearance on 2005-04-15 under 510(k) number K042944. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOME-AWAY SYSTEM, MODEL 1041?

HOME-AWAY SYSTEM, MODEL 1041 is a medical device that received FDA 510(k) clearance on 2005-04-15. The listed applicant is In-X Corporation. The 510(k) number is K042944.

When did HOME-AWAY SYSTEM, MODEL 1041 receive FDA 510(k) clearance?

HOME-AWAY SYSTEM, MODEL 1041 received FDA 510(k) clearance on 2005-04-15, under 510(k) number K042944.

Who is the listed applicant for HOME-AWAY SYSTEM, MODEL 1041?

The FDA 510(k) record lists In-X Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOME-AWAY SYSTEM, MODEL 1041?

The FDA product code for HOME-AWAY SYSTEM, MODEL 1041 is CAW.

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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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