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)

STAR

K-Number: K801917 · 1980-09-16

ApplicantGeneral Electric Co.
Decision Date1980-09-16
Product CodeJWM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STAR is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801917. The device is classified under product code JWM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAR?

STAR is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is General Electric Co.. The 510(k) number is K801917.

When did STAR receive FDA 510(k) clearance?

STAR received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801917.

Who is the listed applicant for STAR?

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

What is the FDA product code for STAR?

The FDA product code for STAR is JWM.

Related PubMed Literature

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.

PMID: 38028345PMDedu: Assessing the educational needs of startups and academic investigators focused on pediatric medical device development.Journal of clinical and translational science ()PMID: 35723914Assessing the Clinical Robustness of Digital Health Startups: Cross-sectional Observational Analysis.Journal of medical Internet research ()

Other records listing General Electric Co. 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.

K103489GE VEO RECONSTRUCTION OPTIONK082317GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTIONK081921GE VIVID E9 ULTRASOUNDK073297GE LOGIQ P6K072952GE ECHOPACK072797GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND

View all 254 devices →

Related Devices (Code: JWM)

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.

K914350ICON COMPUTER SYSTEMSiemens Gammasonics, Inc.K904599D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEMDigital Design, Inc.K903315ICONSiemens Gammasonics, Inc.K901545GCA-9300 NUCLEAR TOMOGRAPHY SYSTEMToshiba America Medical Systems, In.CK874473ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEMAdac LaboratoriesK873075ADAC MODEL ARC-5000, GAMMA CAMERAAdac Laboratories

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.

↑