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 |