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FDA 510(k)

ELECTRODE, NEEDLE, CFM

K-Number: K781311 · 1978-08-21

ApplicantApplied Medical Research
Decision Date1978-08-21
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELECTRODE, NEEDLE, CFM is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Research. It received FDA 510(k) clearance on 1978-08-21 under 510(k) number K781311. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRODE, NEEDLE, CFM?

ELECTRODE, NEEDLE, CFM is a medical device that received FDA 510(k) clearance on 1978-08-21. The listed applicant is Applied Medical Research. The 510(k) number is K781311.

When did ELECTRODE, NEEDLE, CFM receive FDA 510(k) clearance?

ELECTRODE, NEEDLE, CFM received FDA 510(k) clearance on 1978-08-21, under 510(k) number K781311.

Who is the listed applicant for ELECTRODE, NEEDLE, CFM?

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

What is the FDA product code for ELECTRODE, NEEDLE, CFM?

The FDA product code for ELECTRODE, NEEDLE, CFM is GXZ.

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Other records listing Applied Medical Research 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: GXZ)

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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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