The following data is part of a premarket notification filed by Philips Medical Systems Nederland Bv with the FDA for Interventional Workspot.
Device ID | K181177 |
510k Number | K181177 |
Device Name: | Interventional Workspot |
Classification | System, Image Processing, Radiological |
Applicant | Philips Medical Systems Nederland BV Veenpluis 4-6 Best, NL 5684pc |
Contact | Chandrika Srinivasan |
Correspondent | Chandrika Srinivasan Philips Medical Systems Nederland BV Veenpluis 4-6 Best, NL 5684pc |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-05-02 |
Decision Date | 2018-05-31 |
Summary: | summary |