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FDA 510(k)

EMOX

K-Number: K984081 · 1999-03-17

ApplicantEmox 911 CC
Decision Date1999-03-17
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EMOX is the device name listed in this FDA 510(k) record. The listed applicant is Emox 911 CC. It received FDA 510(k) clearance on 1999-03-17 under 510(k) number K984081. 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 EMOX?

EMOX is a medical device that received FDA 510(k) clearance on 1999-03-17. The listed applicant is Emox 911 CC. The 510(k) number is K984081.

When did EMOX receive FDA 510(k) clearance?

EMOX received FDA 510(k) clearance on 1999-03-17, under 510(k) number K984081.

Who is the listed applicant for EMOX?

The FDA 510(k) record lists Emox 911 CC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMOX?

The FDA product code for EMOX is CAW.

Other records listing Emox 911 CC as applicant

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.

K984082BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET

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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