FDA 510(k)

PALI-TRODE

K-Number: K981015 · 1998-06-16

Decision Date1998-06-16

Product CodeGZL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PALI-TRODE is the device name listed in this FDA 510(k) record. The listed applicant is Preferred Instruments. It received FDA 510(k) clearance on 1998-06-16 under 510(k) number K981015. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALI-TRODE?

PALI-TRODE is a medical device that received FDA 510(k) clearance on 1998-06-16. The listed applicant is Preferred Instruments. The 510(k) number is K981015.

When did PALI-TRODE receive FDA 510(k) clearance?

PALI-TRODE received FDA 510(k) clearance on 1998-06-16, under 510(k) number K981015.

Who is the listed applicant for PALI-TRODE?

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

What is the FDA product code for PALI-TRODE?

The FDA product code for PALI-TRODE is GZL.

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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.