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FDA 510(k)

PMT HALO SYSTEM

K-Number: K090733 · 2009-07-28

ApplicantPmt Corp.
Decision Date2009-07-28
Product CodeHAX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PMT HALO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pmt Corp.. It received FDA 510(k) clearance on 2009-07-28 under 510(k) number K090733. The device is classified under product code HAX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PMT HALO SYSTEM?

PMT HALO SYSTEM is a medical device that received FDA 510(k) clearance on 2009-07-28. The listed applicant is Pmt Corp.. The 510(k) number is K090733.

When did PMT HALO SYSTEM receive FDA 510(k) clearance?

PMT HALO SYSTEM received FDA 510(k) clearance on 2009-07-28, under 510(k) number K090733.

Who is the listed applicant for PMT HALO SYSTEM?

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

What is the FDA product code for PMT HALO SYSTEM?

The FDA product code for PMT HALO SYSTEM is HAX.

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Other records listing Pmt Corp. as applicant

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.

K122376PMT TRUSCAN SURFACE ELECTRODEK082474PMT SUBDURAL CORTICAL ELECTRODESK042901ENDOMARK STERILE INDIA INKK033730PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIESK972597PMT NEW BEGINNINGS GELSHAPES & AMENDK970418PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)

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Related Devices (Code: HAX)

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.

K071173RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100DOssur Americans (Formerly the Jerome Group)K051918RESOLVE OPEN BACK HALO RINGSJerome MedicalK023959JEROME GLASS RINGThe Jerome Group, Inc.K003662SPINE WORKS COLLARSpine WorksK980689FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEMFriddle'S Orthopedic Appliances, Inc.K930021J TONGSJerome Medical

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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