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FDA 510(k)

TRAVELSOME STANDARD

K-Number: K030233 · 2003-04-25

ApplicantSim Italia S.R.L.
Decision Date2003-04-25
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRAVELSOME STANDARD is the device name listed in this FDA 510(k) record. The listed applicant is Sim Italia S.R.L.. It received FDA 510(k) clearance on 2003-04-25 under 510(k) number K030233. 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 TRAVELSOME STANDARD?

TRAVELSOME STANDARD is a medical device that received FDA 510(k) clearance on 2003-04-25. The listed applicant is Sim Italia S.R.L.. The 510(k) number is K030233.

When did TRAVELSOME STANDARD receive FDA 510(k) clearance?

TRAVELSOME STANDARD received FDA 510(k) clearance on 2003-04-25, under 510(k) number K030233.

Who is the listed applicant for TRAVELSOME STANDARD?

The FDA 510(k) record lists Sim Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRAVELSOME STANDARD?

The FDA product code for TRAVELSOME STANDARD is CAW.

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Other records listing Sim Italia S.R.L. as applicant

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Related Devices (Code: CAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254289Portable Oxygen Concentrator (OX-1A-E, OX-1B)Oxytek Medical Technology Co., Ltd.K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)BMC Medical Co., Ltd.K252399Portable Oxygen ConcentratorHonsun (Nantong) Co., Ltd.K252965Oxygen Concentrator (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd.K252407OxyGo Portable Oxygen Concentrator (1400-7000)Mv Life, LLCK253549DeVilbiss 5 Liter Oxygen Concentrator (555)Devilbiss Healthcare, LLC

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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