The following data is part of a premarket notification filed by Medicalcommunications Gmbh with the FDA for Ashvins.
| Device ID | K200132 |
| 510k Number | K200132 |
| Device Name: | Ashvins |
| Classification | System, Image Processing, Radiological |
| Applicant | MedicalCommunications GmbH Max-Jarecki-Strasse 8 Heidelberg, DE 69115 |
| Contact | Martin Schinkmann |
| Correspondent | Lena Sattler Orasi Consulting, LLC. 1655 Forest Drive Medina, OH 44256 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-21 |
| Decision Date | 2020-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260648620015 | K200132 | 000 |
| 04260648620008 | K200132 | 000 |
| 04260648620022 | K200132 | 000 |
| 04260648620046 | K200132 | 000 |
| 04260648620039 | K200132 | 000 |
| 04260648620084 | K200132 | 000 |
| 04260648620077 | K200132 | 000 |
| 04260648620060 | K200132 | 000 |
| 04260648620053 | K200132 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ASHVINS 79402654 not registered Live/Pending |
MedicalCommunications GmbH 2024-07-15 |