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FDA 510(k)

MIKADO AC 405

K-Number: K883837 · 1988-12-12

ApplicantIvex Medical, Inc.
Decision Date1988-12-12
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MIKADO AC 405 is the device name listed in this FDA 510(k) record. The listed applicant is Ivex Medical, Inc.. It received FDA 510(k) clearance on 1988-12-12 under 510(k) number K883837. 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 MIKADO AC 405?

MIKADO AC 405 is a medical device that received FDA 510(k) clearance on 1988-12-12. The listed applicant is Ivex Medical, Inc.. The 510(k) number is K883837.

When did MIKADO AC 405 receive FDA 510(k) clearance?

MIKADO AC 405 received FDA 510(k) clearance on 1988-12-12, under 510(k) number K883837.

Who is the listed applicant for MIKADO AC 405?

The FDA 510(k) record lists Ivex Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIKADO AC 405?

The FDA product code for MIKADO AC 405 is CAW.

Related Clinical Trials

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.

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Other records listing Ivex Medical, 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.

K893545IVEX MODEL NO. BP 3000 BREASTPUMPK884563OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3%

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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