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FDA 510(k)

ULTRASOUND GEL

K-Number: K850290 · 1985-04-18

ApplicantLitton Datamedix
Decision Date1985-04-18
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND GEL is the device name listed in this FDA 510(k) record. The listed applicant is Litton Datamedix. It received FDA 510(k) clearance on 1985-04-18 under 510(k) number K850290. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASOUND GEL?

ULTRASOUND GEL is a medical device that received FDA 510(k) clearance on 1985-04-18. The listed applicant is Litton Datamedix. The 510(k) number is K850290.

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

ULTRASOUND GEL received FDA 510(k) clearance on 1985-04-18, under 510(k) number K850290.

Who is the listed applicant for ULTRASOUND GEL?

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

What is the FDA product code for ULTRASOUND GEL?

The FDA product code for ULTRASOUND GEL is IYO.

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Other records listing Litton Datamedix 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.

K853599LITTON DATAMEDIX BLOOD PRESSURE MONITOR NIK842497SERVOMED OXYMONITO SMK 363K842312SERVOCARD SCP-840K842235SERVOCARD DEFIBRILLATOR SCP-851

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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.

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