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)

AIR ALIVE

K-Number: K812320 · 1982-02-24

ApplicantWestern Systems, Inc.
Decision Date1982-02-24
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AIR ALIVE is the device name listed in this FDA 510(k) record. The listed applicant is Western Systems, Inc.. It received FDA 510(k) clearance on 1982-02-24 under 510(k) number K812320. The device is classified under product code FRF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR ALIVE?

AIR ALIVE is a medical device that received FDA 510(k) clearance on 1982-02-24. The listed applicant is Western Systems, Inc.. The 510(k) number is K812320.

When did AIR ALIVE receive FDA 510(k) clearance?

AIR ALIVE received FDA 510(k) clearance on 1982-02-24, under 510(k) number K812320.

Who is the listed applicant for AIR ALIVE?

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

What is the FDA product code for AIR ALIVE?

The FDA product code for AIR ALIVE is FRF.

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

Related Devices (Code: FRF)

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.

K251872Biomoneta Avata RxBiomoneta Research Private LimitedK242102CerroZone MiniCerrozone, LLCK240696Airdog X8 Air Purifier (KJ800F-X8)Suzhou Beiang Smart Technology Co., Ltd.K223835MA-40, MA-112Medify Air, LLCK222416RIA SafeguardRia Tech Co., Ltd.K211507Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)Beiang Air Tech , Ltd.

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.

↑