The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Vereos Pet/ct.
Device ID | K211764 |
510k Number | K211764 |
Device Name: | Vereos PET/CT |
Classification | System, Tomography, Computed, Emission |
Applicant | Philips Medical Systems Nederland B.V. Veenpluis 6 Best, NL 5684 Pc |
Contact | Carmit Shmuel |
Correspondent | Carmit Shmuel Philips Medical Systems Nederland B.V. Veenpluis 6 Best, NL 5684 Pc |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-06-08 |
Decision Date | 2021-08-06 |