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FDA 510(k)

PULSE GUARD ELECTRODE

K-Number: K925396 · 1993-07-30

ApplicantNorthgate Technologies, Inc.
Decision Date1993-07-30
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PULSE GUARD ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Northgate Technologies, Inc.. It received FDA 510(k) clearance on 1993-07-30 under 510(k) number K925396. The device is classified under product code FFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULSE GUARD ELECTRODE?

PULSE GUARD ELECTRODE is a medical device that received FDA 510(k) clearance on 1993-07-30. The listed applicant is Northgate Technologies, Inc.. The 510(k) number is K925396.

When did PULSE GUARD ELECTRODE receive FDA 510(k) clearance?

PULSE GUARD ELECTRODE received FDA 510(k) clearance on 1993-07-30, under 510(k) number K925396.

Who is the listed applicant for PULSE GUARD ELECTRODE?

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

What is the FDA product code for PULSE GUARD ELECTRODE?

The FDA product code for PULSE GUARD ELECTRODE is FFK.

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Other records listing Northgate Technologies, Inc. as applicant

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Related Devices (Code: FFK)

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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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