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FDA 510(k)

ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT

K-Number: K042619 · 2004-11-05

ApplicantSonotech, Inc.
Decision Date2004-11-05
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Sonotech, Inc.. It received FDA 510(k) clearance on 2004-11-05 under 510(k) number K042619. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT?

ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT is a medical device that received FDA 510(k) clearance on 2004-11-05. The listed applicant is Sonotech, Inc.. The 510(k) number is K042619.

When did ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT receive FDA 510(k) clearance?

ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT received FDA 510(k) clearance on 2004-11-05, under 510(k) number K042619.

Who is the listed applicant for ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT?

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

What is the FDA product code for ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT?

The FDA product code for ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT is MUI.

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Other records listing Sonotech, 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.

K033178ULTRABIOK031222SCANLUBEK031894SCANTEC PADK013701ENDO-GLIDEK013170SCANTAC MEMBRANE OR SCANTAC STRIPK984562VIVOSONIC

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Related Devices (Code: MUI)

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.

K253255Non-Sterile Ultrasound Gel Sterile Ultrasound GelFoshan Pingchuang Medical Technology Co., Ltd.K252337EdgeFlow Gel PadEdgecare, Inc.K242167Sterile and Non-Sterile Ultrasonic Coupling AgentAnhui Deepblue Medical Technology Co., Ltd.K241789Non-Sterile Ultrasound Transmission GelsHony Medical Co., Ltd.K232957Sterile and Non-Sterile Ultrasound GelsJianerkang Medical Co., Ltd.K221999Ultrasound Transmission GelsHony Medical Co., Ltd.

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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