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)

ROOMMATE-OXYGEN CONCENTRATOR

K-Number: K801104 · 1980-05-23

ApplicantCryogenic Assoc.
Decision Date1980-05-23
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ROOMMATE-OXYGEN CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Cryogenic Assoc.. It received FDA 510(k) clearance on 1980-05-23 under 510(k) number K801104. 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 ROOMMATE-OXYGEN CONCENTRATOR?

ROOMMATE-OXYGEN CONCENTRATOR is a medical device that received FDA 510(k) clearance on 1980-05-23. The listed applicant is Cryogenic Assoc.. The 510(k) number is K801104.

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

ROOMMATE-OXYGEN CONCENTRATOR received FDA 510(k) clearance on 1980-05-23, under 510(k) number K801104.

Who is the listed applicant for ROOMMATE-OXYGEN CONCENTRATOR?

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

What is the FDA product code for ROOMMATE-OXYGEN CONCENTRATOR?

The FDA product code for ROOMMATE-OXYGEN CONCENTRATOR 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 Cryogenic Assoc. 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.

K883590OXYTROLK852663PORTABLE GASEOUS OXGYEN CONTAINERK841808STROLLER SPRINTK822789ROOMATE IIK800742LIBERATOR/STROLLER II SYSTEM

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.

↑