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FDA 510(k)

RESPO2 OXYGEN CONCENTRATOR

K-Number: K802426 · 1980-10-23

ApplicantMada Medical Products, Inc.
Decision Date1980-10-23
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPO2 OXYGEN CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Mada Medical Products, Inc.. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K802426. 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 RESPO2 OXYGEN CONCENTRATOR?

RESPO2 OXYGEN CONCENTRATOR is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Mada Medical Products, Inc.. The 510(k) number is K802426.

When did RESPO2 OXYGEN CONCENTRATOR receive FDA 510(k) clearance?

RESPO2 OXYGEN CONCENTRATOR received FDA 510(k) clearance on 1980-10-23, under 510(k) number K802426.

Who is the listed applicant for RESPO2 OXYGEN CONCENTRATOR?

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

What is the FDA product code for RESPO2 OXYGEN CONCENTRATOR?

The FDA product code for RESPO2 OXYGEN CONCENTRATOR is CAW.

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Other records listing Mada Medical Products, 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.

K003862MADA WHEELCHAIRSK002943WHEELCHAIR, MECHANICAL SERIES MODEL 3100K950777OXYGEN REGULATORK930947PROMENADEK930949VOYAGEK921611MADAVAC 190

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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