FDA 510(k) · Philips Medical Systems
K192875: Philips Biosensor BX100 (Philips Medical Systems)
Philips Medical Systems received FDA 510(k) K192875 for Philips Biosensor BX100, with a decision date of Apr 16, 2020 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K192875 |
|---|---|
| Pathway | 510(k) |
| Applicant | Philips Medical Systems |
| Device name | Philips Biosensor BX100 |
| Product code | DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Regulation (21 CFR) | 870.2910 |
| Device class | Class 2 |
| Date received | Oct 8, 2019 |
| Decision date | Apr 16, 2020 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Philips Biosensor BX100 is a physiological measurement device for use by healthcare professionals to aid in the treatment and management of patient conditions in general care areas of a hospital. The Philips Biosensor BX100 is intended for use by healthcare professionals on patients 18 years of age and older. This chest-worn biosensor collects, stores, and transmits physiological data and contextual parameters to a qualified backend system. Physiological data includes respiration rate and heart rate; contextual parameters include ambulation, activity level, and posture.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DRG is "Transmitters And Receivers, Physiological Signal, Radiofrequency", class 2, 21 CFR 870.2910.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.