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FDA PMA

Electrical Impedance Spectrometer

PMA Number: P150046 · 2017-06-28

ApplicantScibase AB
Decision Date2017-06-28
PMA NumberP150046
Product CodeONV
Device ClassClass 2
Medical SpecialtyG
Regulation Number21 CFR 8
Advisory CommitteeSU

Device Summary

Electrical Impedance Spectrometer is a medical device manufactured by Scibase AB. It received FDA Premarket Approval (PMA) on 2017-06-28 under PMA number P150046. The device is classified under FDA product code ONV. It was reviewed by the SU advisory panel. This device is classified as Class II by the FDA. Class III devices subject to special controls, in addition to general controls. These devices typically require premarket notification (510(k)). PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of G. It is regulated under 21 CFR Part 8. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is Electrical Impedance Spectrometer?

Electrical Impedance Spectrometer is a medical device that received FDA Premarket Approval (PMA) on 2017-06-28. It is manufactured by Scibase AB. The PMA number is P150046.

When did Electrical Impedance Spectrometer receive FDA PMA approval?

Electrical Impedance Spectrometer received FDA PMA approval on 2017-06-28, under approval number P150046.

What company makes Electrical Impedance Spectrometer?

Electrical Impedance Spectrometer is manufactured by Scibase AB.

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Electrical Impedance Spectrometer?

The FDA product code for Electrical Impedance Spectrometer is ONV.

What FDA device class is Electrical Impedance Spectrometer?

Electrical Impedance Spectrometer is classified as Class II by the FDA.

Related Clinical Trials

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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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