TRANBERG Thermoguide Therapy System

Neurosurgical Laser With Mr Thermography

Clinical Laserthermia Systems AB

The following data is part of a premarket notification filed by Clinical Laserthermia Systems Ab with the FDA for Tranberg Thermoguide Therapy System.

Pre-market Notification Details

Device IDK214125
510k NumberK214125
Device Name:TRANBERG Thermoguide Therapy System
ClassificationNeurosurgical Laser With Mr Thermography
Applicant Clinical Laserthermia Systems AB Scheelevägen 2 Lund,  SE 22381
ContactDan Mogren
CorrespondentJohn Smith
Hogan Lovells US LLP 555 13th Street NW Washington,  DC  20004
Product CodeONO  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-30
Decision Date2022-09-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17340007000888 K214125 000
17340007000871 K214125 000
37340007000868 K214125 000
37340007000851 K214125 000
37340007000844 K214125 000
17340007000833 K214125 000
17340007000826 K214125 000
37340007000950 K214125 000

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