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FDA 510(k)

ACCUTRACKER DX

K-Number: K913844 · 1992-07-14

ApplicantSuntech Medical Instruments, Inc.
Decision Date1992-07-14
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACCUTRACKER DX is the device name listed in this FDA 510(k) record. The listed applicant is Suntech Medical Instruments, Inc.. It received FDA 510(k) clearance on 1992-07-14 under 510(k) number K913844. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUTRACKER DX?

ACCUTRACKER DX is a medical device that received FDA 510(k) clearance on 1992-07-14. The listed applicant is Suntech Medical Instruments, Inc.. The 510(k) number is K913844.

When did ACCUTRACKER DX receive FDA 510(k) clearance?

ACCUTRACKER DX received FDA 510(k) clearance on 1992-07-14, under 510(k) number K913844.

Who is the listed applicant for ACCUTRACKER DX?

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

What is the FDA product code for ACCUTRACKER DX?

The FDA product code for ACCUTRACKER DX is DXN.

Related Clinical Trials

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Other records listing Suntech Medical Instruments, 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.

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Related Devices (Code: DXN)

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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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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