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)

MODEL BION 1/TYPE 1084T CAR IONIZER

K-Number: K851094 · 1985-06-19

ApplicantMedicor USA , Ltd.
Decision Date1985-06-19
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL BION 1/TYPE 1084T CAR IONIZER is the device name listed in this FDA 510(k) record. The listed applicant is Medicor USA , Ltd.. It received FDA 510(k) clearance on 1985-06-19 under 510(k) number K851094. 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 MODEL BION 1/TYPE 1084T CAR IONIZER?

MODEL BION 1/TYPE 1084T CAR IONIZER is a medical device that received FDA 510(k) clearance on 1985-06-19. The listed applicant is Medicor USA , Ltd.. The 510(k) number is K851094.

When did MODEL BION 1/TYPE 1084T CAR IONIZER receive FDA 510(k) clearance?

MODEL BION 1/TYPE 1084T CAR IONIZER received FDA 510(k) clearance on 1985-06-19, under 510(k) number K851094.

Who is the listed applicant for MODEL BION 1/TYPE 1084T CAR IONIZER?

The FDA 510(k) record lists Medicor USA , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL BION 1/TYPE 1084T CAR IONIZER?

The FDA product code for MODEL BION 1/TYPE 1084T CAR IONIZER 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

Other records listing Medicor USA , Ltd. 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.

K861994MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEMK861995MODEL RS-3 RADIOGRAPHIC STANDK860025MODEL MS-325 RADIOGRAPHIC X-RAY GENERATORK850761MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY CK851358MODEL BION 2/TYPE 90 ROOM IONIZERK843335FLOOR MOUNTED X-RAY TUBESTAND

View all 14 devices →

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.

↑