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FDA 510(k)

STERILE ULTRASOUND TRANSMISSION GEL

K-Number: K894490 · 1989-10-05

ApplicantSwedish Trade Council USA
Decision Date1989-10-05
Product CodeJOT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE ULTRASOUND TRANSMISSION GEL is the device name listed in this FDA 510(k) record. The listed applicant is Swedish Trade Council USA. It received FDA 510(k) clearance on 1989-10-05 under 510(k) number K894490. The device is classified under product code JOT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE ULTRASOUND TRANSMISSION GEL?

STERILE ULTRASOUND TRANSMISSION GEL is a medical device that received FDA 510(k) clearance on 1989-10-05. The listed applicant is Swedish Trade Council USA. The 510(k) number is K894490.

When did STERILE ULTRASOUND TRANSMISSION GEL receive FDA 510(k) clearance?

STERILE ULTRASOUND TRANSMISSION GEL received FDA 510(k) clearance on 1989-10-05, under 510(k) number K894490.

Who is the listed applicant for STERILE ULTRASOUND TRANSMISSION GEL?

The FDA 510(k) record lists Swedish Trade Council USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE ULTRASOUND TRANSMISSION GEL?

The FDA product code for STERILE ULTRASOUND TRANSMISSION GEL is JOT.

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 Swedish Trade Council USA 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.

K903034RENALYZER PRX 90

Related Devices (Code: JOT)

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.

K923647RFG-DGP DISPOSABLE GROUNDING PADSRadionics, Inc.K905545ULTRASOUND TRANSMISSION GELArbo Medical, Inc.K904418ULTRASOUND COUPLING GELGeno LaboratoriesK901217TRIA-SONIC ULTRA SOUND TRANSMISSION GELH & P Industries, Inc.K884503ULTRASONIC TRANSMISSION GELHerbert Stanley Co.K872519STERILIZED OMNI GELEcho Ultrasound

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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