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FDA 510(k)

KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE

K-Number: K110462 · 2011-09-26

ApplicantKepler Medtec
Decision Date2011-09-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE is the device name listed in this FDA 510(k) record. The listed applicant is Kepler Medtec. It received FDA 510(k) clearance on 2011-09-26 under 510(k) number K110462. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE?

KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE is a medical device that received FDA 510(k) clearance on 2011-09-26. The listed applicant is Kepler Medtec. The 510(k) number is K110462.

When did KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE receive FDA 510(k) clearance?

KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE received FDA 510(k) clearance on 2011-09-26, under 510(k) number K110462.

Who is the listed applicant for KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE?

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

What is the FDA product code for KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE?

The FDA product code for KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE is GEI.

Related Clinical Trials

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Other records listing Kepler Medtec 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.

K101660ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8

Related Devices (Code: GEI)

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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