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FDA 510(k)

SCANTAC MEMBRANE OR SCANTAC STRIP

K-Number: K013170 · 2001-11-13

ApplicantSonotech, Inc.
Decision Date2001-11-13
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SCANTAC MEMBRANE OR SCANTAC STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Sonotech, Inc.. It received FDA 510(k) clearance on 2001-11-13 under 510(k) number K013170. 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 SCANTAC MEMBRANE OR SCANTAC STRIP?

SCANTAC MEMBRANE OR SCANTAC STRIP is a medical device that received FDA 510(k) clearance on 2001-11-13. The listed applicant is Sonotech, Inc.. The 510(k) number is K013170.

When did SCANTAC MEMBRANE OR SCANTAC STRIP receive FDA 510(k) clearance?

SCANTAC MEMBRANE OR SCANTAC STRIP received FDA 510(k) clearance on 2001-11-13, under 510(k) number K013170.

Who is the listed applicant for SCANTAC MEMBRANE OR SCANTAC STRIP?

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 SCANTAC MEMBRANE OR SCANTAC STRIP?

The FDA product code for SCANTAC MEMBRANE OR SCANTAC STRIP 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-GLIDEK984562VIVOSONIC

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Related Devices (Code: ITX)

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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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