The following data is part of a premarket notification filed by Vbm Medizintechnik Gmbh with the FDA for Scalpelcric.
| Device ID | K200190 |
| 510k Number | K200190 |
| Device Name: | ScalpelCric |
| Classification | Needle, Emergency Airway |
| Applicant | VBM Medizintechnik GmbH Einsteinstrasse 1 Sulz Am Neckar, DE 72172 |
| Contact | Jannika Jaeger |
| Correspondent | Jannika Jaeger VBM Medizintechnik GmbH Einsteinstrasse 1 Sulz Am Neckar, DE 72172 |
| Product Code | BWC |
| CFR Regulation Number | 868.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-27 |
| Decision Date | 2020-10-30 |