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FDA 510(k)

ULTRASOUND COUPLING GEL

K-Number: K904418 · 1991-02-11

ApplicantGeno Laboratories
Decision Date1991-02-11
Product CodeJOT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND COUPLING GEL is the device name listed in this FDA 510(k) record. The listed applicant is Geno Laboratories. It received FDA 510(k) clearance on 1991-02-11 under 510(k) number K904418. 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 ULTRASOUND COUPLING GEL?

ULTRASOUND COUPLING GEL is a medical device that received FDA 510(k) clearance on 1991-02-11. The listed applicant is Geno Laboratories. The 510(k) number is K904418.

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

ULTRASOUND COUPLING GEL received FDA 510(k) clearance on 1991-02-11, under 510(k) number K904418.

Who is the listed applicant for ULTRASOUND COUPLING GEL?

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

What is the FDA product code for ULTRASOUND COUPLING GEL?

The FDA product code for ULTRASOUND COUPLING GEL is JOT.

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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.K901217TRIA-SONIC ULTRA SOUND TRANSMISSION GELH & P Industries, Inc.K894490STERILE ULTRASOUND TRANSMISSION GELSwedish Trade Council USAK884503ULTRASONIC 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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