The following data is part of a premarket notification filed by Philips Medical Systems Nederlands B.v. with the FDA for Smartperfusion.
| Device ID | K181966 |
| 510k Number | K181966 |
| Device Name: | SmartPerfusion |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Philips Medical Systems Nederlands B.V. Veenpluis 4-6 Best, NL 5684pc |
| Contact | Chandrika Srinivasan |
| Correspondent | Chandrika Srinivasan Philips Medical Systems Nederlands B.V. Veenpluis 4-6 Best, NL 5684pc |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-23 |
| Decision Date | 2018-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838088566 | K181966 | 000 |