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FDA 510(k)

VERSATEC 310 ELECTRODE

K-Number: K963975 · 1997-01-07

ApplicantVersatec, Inc.
Decision Date1997-01-07
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VERSATEC 310 ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Versatec, Inc.. It received FDA 510(k) clearance on 1997-01-07 under 510(k) number K963975. 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 VERSATEC 310 ELECTRODE?

VERSATEC 310 ELECTRODE is a medical device that received FDA 510(k) clearance on 1997-01-07. The listed applicant is Versatec, Inc.. The 510(k) number is K963975.

When did VERSATEC 310 ELECTRODE receive FDA 510(k) clearance?

VERSATEC 310 ELECTRODE received FDA 510(k) clearance on 1997-01-07, under 510(k) number K963975.

Who is the listed applicant for VERSATEC 310 ELECTRODE?

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

What is the FDA product code for VERSATEC 310 ELECTRODE?

The FDA product code for VERSATEC 310 ELECTRODE is DRX.

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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

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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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