Submission Details
| 510(k) Number | K192875 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 08, 2019 |
| Decision Date | April 16, 2020 |
| Days to Decision | 191 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Philips Biosensor BX100
Apr 2020
Decision
191d
Days
Class 2
Risk
About This 510(k) Submission
K192875 is an FDA 510(k) clearance for the Philips Biosensor BX100, a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II — Special Controls, product code DRG), submitted by Philips Medical Systems (Cambridge, US). The FDA issued a Cleared decision on April 16, 2020, 191 days after receiving the submission on October 8, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2910.
Device Classification
| Product Code | DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2910 |
Manufacturer
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