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FDA 510(k)

T65 (9016E061-)

K-Number: K252032 · 2025-07-30

ApplicantTonica Elektronik A/S
Decision Date2025-07-30
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

T65 (9016E061-) is the device name listed in this FDA 510(k) record. The listed applicant is Tonica Elektronik A/S. It received FDA 510(k) clearance on 2025-07-30 under 510(k) number K252032. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T65 (9016E061-)?

T65 (9016E061-) is a medical device that received FDA 510(k) clearance on 2025-07-30. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K252032.

When did T65 (9016E061-) receive FDA 510(k) clearance?

T65 (9016E061-) received FDA 510(k) clearance on 2025-07-30, under 510(k) number K252032.

Who is the listed applicant for T65 (9016E061-)?

The FDA 510(k) record lists Tonica Elektronik A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T65 (9016E061-)?

The FDA product code for T65 (9016E061-) is OBP.

Other records listing Tonica Elektronik A/S as applicant

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Related Devices (Code: OBP)

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.

K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbHK260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/SK253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK251653SPRY TMS Therapy System (0550)Soterix Medical, Inc.

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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