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FDA 510(k)

PULSE GUARD 3FR ELECTRODE

K-Number: K944571 · 1995-03-17

ApplicantNorthgate Technologies, Inc.
Decision Date1995-03-17
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PULSE GUARD 3FR 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 1995-03-17 under 510(k) number K944571. 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 3FR ELECTRODE?

PULSE GUARD 3FR ELECTRODE is a medical device that received FDA 510(k) clearance on 1995-03-17. The listed applicant is Northgate Technologies, Inc.. The 510(k) number is K944571.

When did PULSE GUARD 3FR ELECTRODE receive FDA 510(k) clearance?

PULSE GUARD 3FR ELECTRODE received FDA 510(k) clearance on 1995-03-17, under 510(k) number K944571.

Who is the listed applicant for PULSE GUARD 3FR 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 3FR ELECTRODE?

The FDA product code for PULSE GUARD 3FR ELECTRODE is 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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