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FDA 510(k)

AMERITEK SURE-POINT TRACKER SYSTEM

K-Number: K030518 · 2003-05-20

ApplicantAmertek Medical, Inc.
Decision Date2003-05-20
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AMERITEK SURE-POINT TRACKER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Amertek Medical, Inc.. It received FDA 510(k) clearance on 2003-05-20 under 510(k) number K030518. 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 AMERITEK SURE-POINT TRACKER SYSTEM?

AMERITEK SURE-POINT TRACKER SYSTEM is a medical device that received FDA 510(k) clearance on 2003-05-20. The listed applicant is Amertek Medical, Inc.. The 510(k) number is K030518.

When did AMERITEK SURE-POINT TRACKER SYSTEM receive FDA 510(k) clearance?

AMERITEK SURE-POINT TRACKER SYSTEM received FDA 510(k) clearance on 2003-05-20, under 510(k) number K030518.

Who is the listed applicant for AMERITEK SURE-POINT TRACKER SYSTEM?

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

What is the FDA product code for AMERITEK SURE-POINT TRACKER SYSTEM?

The FDA product code for AMERITEK SURE-POINT TRACKER SYSTEM is ITX.

Related Clinical Trials

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.

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Other records listing Amertek Medical, 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.

K031273AMERITEK SURE-POINT HDR NEEDLE TEMPLATEK011581AMERITEK BRACHYTHERAPY TEMPLATE

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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