Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PORTABLE OXYGEN GENERATOR

K-Number: K884084 · 1988-11-21

ApplicantMountain Medical Equipment, Inc.
Decision Date1988-11-21
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTABLE OXYGEN GENERATOR 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 1988-11-21 under 510(k) number K884084. 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 PORTABLE OXYGEN GENERATOR?

PORTABLE OXYGEN GENERATOR is a medical device that received FDA 510(k) clearance on 1988-11-21. The listed applicant is Mountain Medical Equipment, Inc.. The 510(k) number is K884084.

When did PORTABLE OXYGEN GENERATOR receive FDA 510(k) clearance?

PORTABLE OXYGEN GENERATOR received FDA 510(k) clearance on 1988-11-21, under 510(k) number K884084.

Who is the listed applicant for PORTABLE OXYGEN GENERATOR?

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 PORTABLE OXYGEN GENERATOR?

The FDA product code for PORTABLE OXYGEN GENERATOR 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 20 devices →

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.

↑