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FDA 510(k)

EMOX

K-Number: K954506 · 1996-04-30

ApplicantMedtrak Intl., Inc.
Decision Date1996-04-30
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EMOX is the device name listed in this FDA 510(k) record. The listed applicant is Medtrak Intl., Inc.. It received FDA 510(k) clearance on 1996-04-30 under 510(k) number K954506. 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 1996-04-30. The listed applicant is Medtrak Intl., Inc.. The 510(k) number is K954506.

When did EMOX receive FDA 510(k) clearance?

EMOX received FDA 510(k) clearance on 1996-04-30, under 510(k) number K954506.

Who is the listed applicant for EMOX?

The FDA 510(k) record lists Medtrak Intl., Inc. 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 Medtrak Intl., Inc. 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.

K961067BURN-AID HYDROGEL,BURN DRESSING,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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