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FDA 510(k)

ROGS

K-Number: K131016 · 2013-11-27

ApplicantMolecular Products , Ltd.
Decision Date2013-11-27
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ROGS is the device name listed in this FDA 510(k) record. The listed applicant is Molecular Products , Ltd.. It received FDA 510(k) clearance on 2013-11-27 under 510(k) number K131016. 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 ROGS?

ROGS is a medical device that received FDA 510(k) clearance on 2013-11-27. The listed applicant is Molecular Products , Ltd.. The 510(k) number is K131016.

When did ROGS receive FDA 510(k) clearance?

ROGS received FDA 510(k) clearance on 2013-11-27, under 510(k) number K131016.

Who is the listed applicant for ROGS?

The FDA 510(k) record lists Molecular Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROGS?

The FDA product code for ROGS is CAW.

Other records listing Molecular Products , Ltd. 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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