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FDA 510(k)

INTCO TAB ELECTRODE

K-Number: K093327 · 2010-05-10

ApplicantShanghai Intco Electrode Manufacturing Co., Ltd.
Decision Date2010-05-10
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTCO TAB ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Intco Electrode Manufacturing Co., Ltd.. It received FDA 510(k) clearance on 2010-05-10 under 510(k) number K093327. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTCO TAB ELECTRODE?

INTCO TAB ELECTRODE is a medical device that received FDA 510(k) clearance on 2010-05-10. The listed applicant is Shanghai Intco Electrode Manufacturing Co., Ltd.. The 510(k) number is K093327.

When did INTCO TAB ELECTRODE receive FDA 510(k) clearance?

INTCO TAB ELECTRODE received FDA 510(k) clearance on 2010-05-10, under 510(k) number K093327.

Who is the listed applicant for INTCO TAB ELECTRODE?

The FDA 510(k) record lists Shanghai Intco Electrode Manufacturing Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTCO TAB ELECTRODE?

The FDA product code for INTCO TAB ELECTRODE is DRX.

Related Clinical Trials

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Other records listing Shanghai Intco Electrode Manufacturing Co., Ltd. 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.

K041954DISPOSABLE MONITORING ELECTRODES

Related Devices (Code: DRX)

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

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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