The following data is part of a premarket notification filed by Philips Medical Systems Nederland Bv with the FDA for Zenition 70.
| Device ID | K183040 |
| 510k Number | K183040 |
| Device Name: | Zenition 70 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Philips Medical Systems Nederland BV Veenpluis 4-6 Best, NL 5684pc |
| Contact | Sumit Kumar |
| Correspondent | Sumit Kumar Philips Medical Systems Nederland BV Veenpluis 4-6 Best, NL 5684pc |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-01 |
| Decision Date | 2018-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838091528 | K183040 | 000 |