The following data is part of a premarket notification filed by Withings with the FDA for Withings Blood Presure Monitor.
| Device ID | K133125 |
| 510k Number | K133125 |
| Device Name: | WITHINGS BLOOD PRESURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | WITHINGS 20 RUE ROUGET DE LISLE Issy Les Moulineaux, FR 92130 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min WITHINGS 20 RUE ROUGET DE LISLE Issy Les Moulineaux, FR 92130 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2014-03-24 |
| Summary: | summary |