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NexSpeech analyzer software

FDA UDI

Class II (US FDA UDI)

by Nexstim Oyj

Identity

Trade Name
NexSpeech analyzer software FDA UDI
Generic Name
Stereotactic neuronavigation/planning system FDA UDI
Device Name
NexSpeech Analyzer Software FDA UDI
Model / Reference
2 FDA UDI
Description
NexSpeech Analyzer Software FDA UDI

Identifiers

Primary DI / UDI-DI
06430063200033 FDA UDI
510(k) Number
K112881 FDA UDI
FDA Product Code
GWF FDA UDI
IKN FDA UDI
HAW FDA UDI
GMDN Term
Stereotactic neuronavigation/planning system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1870 FDA UDI
890.1375 FDA UDI
882.4560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: ElectromyographStereotactic neuronavigation/planning systemHand-held deep-tissue electromagnetic stimulator

NexSpeech analyzer software by Nexstim Oyj — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hand-held deep-tissue electromagnetic stimulator.

Cleared under the same submission

K112881 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nexstim Oyj

Sources (1)

  • FDA UDI bd035dd2-46d1-41e9-8e48-eadbf9fdc080 35 fields · synced Jun 1, 2026