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FDA 510(k)

SCANFLEX SOLID COUPLANT MEMBRANE

K-Number: K983691 · 1999-05-05

ApplicantSonotech, Inc.
Decision Date1999-05-05
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SCANFLEX SOLID COUPLANT MEMBRANE is the device name listed in this FDA 510(k) record. The listed applicant is Sonotech, Inc.. It received FDA 510(k) clearance on 1999-05-05 under 510(k) number K983691. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCANFLEX SOLID COUPLANT MEMBRANE?

SCANFLEX SOLID COUPLANT MEMBRANE is a medical device that received FDA 510(k) clearance on 1999-05-05. The listed applicant is Sonotech, Inc.. The 510(k) number is K983691.

When did SCANFLEX SOLID COUPLANT MEMBRANE receive FDA 510(k) clearance?

SCANFLEX SOLID COUPLANT MEMBRANE received FDA 510(k) clearance on 1999-05-05, under 510(k) number K983691.

Who is the listed applicant for SCANFLEX SOLID COUPLANT MEMBRANE?

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 SCANFLEX SOLID COUPLANT MEMBRANE?

The FDA product code for SCANFLEX SOLID COUPLANT MEMBRANE is ITX.

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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.

K042619ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANTK033178ULTRABIOK031222SCANLUBEK031894SCANTEC PADK013701ENDO-GLIDEK013170SCANTAC MEMBRANE OR SCANTAC STRIP

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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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