The following data is part of a premarket notification filed by Clinical Laserthermia Systems Ab with the FDA for Tranberg Thermoguide Therapy System.
| Device ID | K214125 |
| 510k Number | K214125 |
| Device Name: | TRANBERG Thermoguide Therapy System |
| Classification | Neurosurgical Laser With Mr Thermography |
| Applicant | Clinical Laserthermia Systems AB Scheelevägen 2 Lund, SE 22381 |
| Contact | Dan Mogren |
| Correspondent | John Smith Hogan Lovells US LLP 555 13th Street NW Washington, DC 20004 |
| Product Code | ONO |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-30 |
| Decision Date | 2022-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17340007000888 | K214125 | 000 |
| 17340007000871 | K214125 | 000 |
| 37340007000868 | K214125 | 000 |
| 37340007000851 | K214125 | 000 |
| 37340007000844 | K214125 | 000 |
| 17340007000833 | K214125 | 000 |
| 17340007000826 | K214125 | 000 |