The following data is part of a premarket notification filed by Philips India Limited with the FDA for Stentboost Mobile.
| Device ID | K203623 |
| 510k Number | K203623 |
| Device Name: | StentBoost Mobile |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Philips India Limited Plot No. B-79, MIDC, Phase-II, Chakan, Taluka- Khed, Village - Savardari Pune, IN 410501 |
| Contact | Shruti Sancheti |
| Correspondent | Shruti Sancheti Philips India Limited Plot No. B-79, MIDC, Phase-II, Chakan, Taluka- Khed, Village - Savardari Pune, IN 410501 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-11 |
| Decision Date | 2021-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838103450 | K203623 | 000 |