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)

SPX GENERATOR

K-Number: K842348 · 1984-08-17

ApplicantGeneral Electric Co.
Decision Date1984-08-17
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SPX GENERATOR 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 1984-08-17 under 510(k) number K842348. The device is classified under product code IZO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPX GENERATOR?

SPX GENERATOR is a medical device that received FDA 510(k) clearance on 1984-08-17. The listed applicant is General Electric Co.. The 510(k) number is K842348.

When did SPX GENERATOR receive FDA 510(k) clearance?

SPX GENERATOR received FDA 510(k) clearance on 1984-08-17, under 510(k) number K842348.

Who is the listed applicant for SPX GENERATOR?

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 SPX GENERATOR?

The FDA product code for SPX GENERATOR is IZO.

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 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: IZO)

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.

K954666MPH50, MPH65, AND MPH80GE Medical SystemsK953582HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATORVarian Canada, Inc.K953831N 800 HFNucletron-Oldelft Corp.K952822SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150GShimadzu Corp.K952265MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATORControl-X, Inc.K950883POLYDOROS SX 65 AND 80Siemens Medical Solutions USA, Inc.

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.

↑