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FDA 510(k)

SIERRA -OXYGEN CONCENTRATE

K-Number: K852144 · 1985-08-13

ApplicantMountain Medical Equipment, Inc.
Decision Date1985-08-13
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SIERRA -OXYGEN CONCENTRATE is the device name listed in this FDA 510(k) record. The listed applicant is Mountain Medical Equipment, Inc.. It received FDA 510(k) clearance on 1985-08-13 under 510(k) number K852144. 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 SIERRA -OXYGEN CONCENTRATE?

SIERRA -OXYGEN CONCENTRATE is a medical device that received FDA 510(k) clearance on 1985-08-13. The listed applicant is Mountain Medical Equipment, Inc.. The 510(k) number is K852144.

When did SIERRA -OXYGEN CONCENTRATE receive FDA 510(k) clearance?

SIERRA -OXYGEN CONCENTRATE received FDA 510(k) clearance on 1985-08-13, under 510(k) number K852144.

Who is the listed applicant for SIERRA -OXYGEN CONCENTRATE?

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

What is the FDA product code for SIERRA -OXYGEN CONCENTRATE?

The FDA product code for SIERRA -OXYGEN CONCENTRATE is CAW.

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Other records listing Mountain Medical Equipment, 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.

K941793OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.)K923650SCOTTYK924684MICROFLOWK914916ALPINE VK902890ASPEN 3 OXYGEN CONCENTRATORK893531CUFF SPECULUM

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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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