The following data is part of a premarket notification filed by Visible Patient, Sas with the FDA for Visible Patient Suite.
Device ID | K151988 |
510k Number | K151988 |
Device Name: | Visible Patient Suite |
Classification | System, Image Processing, Radiological |
Applicant | VISIBLE PATIENT, SAS 1 PLACE DE L'HOPITAL Strasbourg, FR 67091 |
Contact | Aude Petitjean |
Correspondent | John J. Smith HOGAN LOVELLS US LLP 555 THIRTEENTH STREET, NW Washington, DC 20004 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-17 |
Decision Date | 2015-10-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B373VPS1090 | K151988 | 000 |
B373VPS10110 | K151988 | 000 |
B373VPS10100 | K151988 | 000 |
B373VPS10150 | K151988 | 000 |
B373VPS10140 | K151988 | 000 |
B373VPS10130 | K151988 | 000 |