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FDA 510(k)

ECO CHECK (ECOVALVE AND OXYGEN MONITOR)

K-Number: K951882 · 1995-10-16

ApplicantAirsep Corp.
Decision Date1995-10-16
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ECO CHECK (ECOVALVE AND OXYGEN MONITOR) is the device name listed in this FDA 510(k) record. The listed applicant is Airsep Corp.. It received FDA 510(k) clearance on 1995-10-16 under 510(k) number K951882. 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 ECO CHECK (ECOVALVE AND OXYGEN MONITOR)?

ECO CHECK (ECOVALVE AND OXYGEN MONITOR) is a medical device that received FDA 510(k) clearance on 1995-10-16. The listed applicant is Airsep Corp.. The 510(k) number is K951882.

When did ECO CHECK (ECOVALVE AND OXYGEN MONITOR) receive FDA 510(k) clearance?

ECO CHECK (ECOVALVE AND OXYGEN MONITOR) received FDA 510(k) clearance on 1995-10-16, under 510(k) number K951882.

Who is the listed applicant for ECO CHECK (ECOVALVE AND OXYGEN MONITOR)?

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

What is the FDA product code for ECO CHECK (ECOVALVE AND OXYGEN MONITOR)?

The FDA product code for ECO CHECK (ECOVALVE AND OXYGEN MONITOR) is CAW.

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Other records listing Airsep Corp. 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.

K101154CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-LK080348OXISCAN II DATA MANAGEMENT SYSTEMK020324LIFESTYLE OXYGEN CONCENTRATORK012037HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009K000963DA VINCHI EEG AND EMG/EP SYSTEMSK001579IMPULSE SELECT

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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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