The following data is part of a premarket notification filed by Philips India Limited with the FDA for Mobilediagnost M50.
| Device ID | K173187 |
| 510k Number | K173187 |
| Device Name: | MobileDiagnost M50 |
| Classification | System, X-ray, Mobile |
| Applicant | Philips India Limited Plot No. B-79, MIDC, Phase II, Chakan, Taluka-Khed Village - Savardari Pune, IN 410501 |
| Contact | Nidhi Bathwal |
| Correspondent | Nidhi Bathwal Philips India Limited Plot No. B-79, MIDC, Phase II, Chakan, Taluka-Khed Village - Savardari Pune, IN 410501 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-02 |
| Decision Date | 2017-11-16 |
| Summary: | summary |