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FDA 510(k)

FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130

K-Number: K030297 · 2003-04-28

ApplicantEnraf-Nonius, B.V.
Decision Date2003-04-28
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 is the device name listed in this FDA 510(k) record. The listed applicant is Enraf-Nonius, B.V.. It received FDA 510(k) clearance on 2003-04-28 under 510(k) number K030297. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130?

FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 is a medical device that received FDA 510(k) clearance on 2003-04-28. The listed applicant is Enraf-Nonius, B.V.. The 510(k) number is K030297.

When did FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 receive FDA 510(k) clearance?

FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 received FDA 510(k) clearance on 2003-04-28, under 510(k) number K030297.

Who is the listed applicant for FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130?

The FDA 510(k) record lists Enraf-Nonius, B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130?

The FDA product code for FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 is GXY.

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 Enraf-Nonius, B.V. 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.

K251083Compact IIK243112Curapuls 670K230472Sonopuls 190

Related Devices (Code: GXY)

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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