FDA 510(k)

PMT Platinum Depthalon Depth Electrode

K-Number: K151790 · 2016-07-14

Decision Date2016-07-14

Product CodeGZL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PMT Platinum Depthalon Depth Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Pmt Corporation. It received FDA 510(k) clearance on 2016-07-14 under 510(k) number K151790. 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 PMT Platinum Depthalon Depth Electrode?

PMT Platinum Depthalon Depth Electrode is a medical device that received FDA 510(k) clearance on 2016-07-14. The listed applicant is Pmt Corporation. The 510(k) number is K151790.

When did PMT Platinum Depthalon Depth Electrode receive FDA 510(k) clearance?

PMT Platinum Depthalon Depth Electrode received FDA 510(k) clearance on 2016-07-14, under 510(k) number K151790.

Who is the listed applicant for PMT Platinum Depthalon Depth Electrode?

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

What is the FDA product code for PMT Platinum Depthalon Depth Electrode?

The FDA product code for PMT Platinum Depthalon Depth Electrode is GZL.

Related Clinical Trials

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.

NCT03567213Investigation on the Cortical Communication (CortiCom) SystemRECRUITING

Other records listing Pmt Corporation as applicant

K202542Allura Vaginal Stent

Related Devices (Code: GZL)

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.