PMT HALO SYSTEM— 510(k) K090733

Substantially Equivalent

Pmt Corp.

FDA 510(k) clearance K090733 for PMT HALO SYSTEM, Substantially Equivalent on 2009-07-28. Applicant: Pmt Corp.. Device class: 2.

Clearance details

Applicant: Pmt Corp.
Product code: Code HAX
Device class: Class 2
Regulation: 21 CFR 882.5960
Advisory panel: Neurology
Date received: 2009-03-19
Decision date: 2009-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chanhassen, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HAX

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K980689 — FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM1999-02-18

More clearances from Pmt Corp.

K122376 — PMT TRUSCAN SURFACE ELECTRODE2012-12-19
K082474 — PMT SUBDURAL CORTICAL ELECTRODES2009-05-08
K042901 — ENDOMARK STERILE INDIA INK2005-03-16
K033730 — PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES2004-08-03
K972597 — PMT NEW BEGINNINGS GELSHAPES & AMEND1997-10-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.