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FDA 510(k)

OCD MT Cap (85-00397-000)

K-Number: K231350 · 2023-06-08

ApplicantNeuronetics
Decision Date2023-06-08
Product CodeQCI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OCD MT Cap (85-00397-000) is a medical device manufactured by Neuronetics. It received FDA 510(k) clearance on 2023-06-08 under approval number K231350. The device is classified under product code QCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCD MT Cap (85-00397-000)?

OCD MT Cap (85-00397-000) is a medical device that received FDA 510(k) clearance on 2023-06-08. It is manufactured by Neuronetics. The 510(k) number is K231350.

When was OCD MT Cap (85-00397-000) approved by the FDA?

OCD MT Cap (85-00397-000) received FDA 510(k) clearance on 2023-06-08, under approval number K231350.

What company makes OCD MT Cap (85-00397-000)?

OCD MT Cap (85-00397-000) is manufactured by Neuronetics.

What is the FDA product code for OCD MT Cap (85-00397-000)?

The FDA product code for OCD MT Cap (85-00397-000) is QCI.

Other Devices by Neuronetics

Related Devices (Code: QCI)

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.