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FDA 510(k)

OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3%

K-Number: K884563 · 1989-04-26

ApplicantIvex Medical, Inc.
Decision Date1989-04-26
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3% 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 1989-04-26 under 510(k) number K884563. 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 OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3%?

OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3% is a medical device that received FDA 510(k) clearance on 1989-04-26. The listed applicant is Ivex Medical, Inc.. The 510(k) number is K884563.

When did OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3% receive FDA 510(k) clearance?

OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3% received FDA 510(k) clearance on 1989-04-26, under 510(k) number K884563.

Who is the listed applicant for OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3%?

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 OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3%?

The FDA product code for OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3% is CAW.

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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 BREASTPUMPK883837MIKADO AC 405

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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