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FDA 510(k)

CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL

K-Number: K931909 · 1994-09-29

ApplicantSonomed Technology, Inc.
Decision Date1994-09-29
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL is the device name listed in this FDA 510(k) record. The listed applicant is Sonomed Technology, Inc.. It received FDA 510(k) clearance on 1994-09-29 under 510(k) number K931909. 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 CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL?

CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL is a medical device that received FDA 510(k) clearance on 1994-09-29. The listed applicant is Sonomed Technology, Inc.. The 510(k) number is K931909.

When did CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL receive FDA 510(k) clearance?

CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL received FDA 510(k) clearance on 1994-09-29, under 510(k) number K931909.

Who is the listed applicant for CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL?

The FDA 510(k) record lists Sonomed Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL?

The FDA product code for CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL is IYO.

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Other records listing Sonomed Technology, Inc. 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.

K931908SONOQUICK ULTRASOUND GELK883917NATURAL IMAGE ULTRASOUND TRANSMISSION COUPLANTK844031SONOMED TECH OPHTHALMIC B-SCAN B-3000K843696OPHTHALMIC A-SCAN A-2000 SONOME

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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