FDA 510(k)

SENOGRAPHE 600T AND 600TS SENIX HF

K-Number: K881882 · 1988-05-25

Decision Date1988-05-25

Product CodeIZH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SENOGRAPHE 600T AND 600TS SENIX HF 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 1988-05-25 under 510(k) number K881882. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENOGRAPHE 600T AND 600TS SENIX HF?

SENOGRAPHE 600T AND 600TS SENIX HF is a medical device that received FDA 510(k) clearance on 1988-05-25. The listed applicant is General Electric Co.. The 510(k) number is K881882.

When did SENOGRAPHE 600T AND 600TS SENIX HF receive FDA 510(k) clearance?

SENOGRAPHE 600T AND 600TS SENIX HF received FDA 510(k) clearance on 1988-05-25, under 510(k) number K881882.

Who is the listed applicant for SENOGRAPHE 600T AND 600TS SENIX HF?

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 SENOGRAPHE 600T AND 600TS SENIX HF?

The FDA product code for SENOGRAPHE 600T AND 600TS SENIX HF is IZH.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing General Electric Co. as applicant

K103489GE VEO RECONSTRUCTION OPTION K082317GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION K081921GE VIVID E9 ULTRASOUND K073297GE LOGIQ P6 K072952GE ECHOPAC K072797GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND

View all 254 devices →

Related Devices (Code: IZH)

K203509SMART FINDERIms Giotto S.P.A.K202294Affirm Contrast BiopsyHologic, Inc.K191495Biopsy PositionerFujifilm Corporation K161575Affirm Lateral Arm Upright Biopsy AccessoryHologic K161920Comfort CoverPrecision Dynamics Corporation K153486Affirm Prone Biopsy SystemHologic, 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.