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FDA 510(k)

CLEARSCAN

K-Number: K080119 · 2008-02-21

ApplicantEsi, Inc.
Decision Date2008-02-21
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CLEARSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Esi, Inc.. It received FDA 510(k) clearance on 2008-02-21 under 510(k) number K080119. 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 CLEARSCAN?

CLEARSCAN is a medical device that received FDA 510(k) clearance on 2008-02-21. The listed applicant is Esi, Inc.. The 510(k) number is K080119.

When did CLEARSCAN receive FDA 510(k) clearance?

CLEARSCAN received FDA 510(k) clearance on 2008-02-21, under 510(k) number K080119.

Who is the listed applicant for CLEARSCAN?

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

What is the FDA product code for CLEARSCAN?

The FDA product code for CLEARSCAN is ITX.

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Other records listing Esi, 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.

K082893PRAGER SHELL

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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