The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Biosensor Bx100.
| Device ID | K192875 |
| 510k Number | K192875 |
| Device Name: | Philips Biosensor BX100 |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | Philips Medical Systems 2 Canal Park Cambridge, MA 02141 |
| Contact | Suzanne Goodman |
| Correspondent | Suzanne Goodman Philips Medical Systems 2 Canal Park Cambridge, MA 02141 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-08 |
| Decision Date | 2020-04-16 |