The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for E-cath Stim Acc. Tsui.
| Device ID | K202699 |
| 510k Number | K202699 |
| Device Name: | E-Cath STIM Acc. Tsui |
| Classification | Anesthesia Conduction Kit |
| Applicant | PAJUNK GmbH Medizintechnologie Karl-Hall-Str 1 Geisingen, DE 78187 |
| Contact | Christian G.h. Quass |
| Correspondent | Christian G.h. Quass PAJUNK GmbH Medizintechnologie Karl-Hall-Str. 1 Geisingen, DE 78187 |
| Product Code | CAZ |
| Subsequent Product Code | BSO |
| Subsequent Product Code | BSP |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-16 |
| Decision Date | 2020-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048223092842 | K202699 | 000 |
| 04048223070604 | K202699 | 000 |