Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit

K-Number: K200848 · 2020-08-14

Decision Date2020-08-14
Product CodeGZF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit is a medical device manufactured by Micron Medical Corporation. It received FDA 510(k) clearance on 2020-08-14 under approval number K200848. The device is classified under product code GZF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit?

Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit is a medical device that received FDA 510(k) clearance on 2020-08-14. It is manufactured by Micron Medical Corporation. The 510(k) number is K200848.

When was Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit approved by the FDA?

Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit received FDA 510(k) clearance on 2020-08-14, under approval number K200848.

What company makes Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit?

Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit is manufactured by Micron Medical Corporation.

What is the FDA product code for Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit?

The FDA product code for Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit is GZF.

Related Clinical Trials

Related Devices (Code: GZF)

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.