QuantaFlo
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
SEMLER SCIENTIFIC, INC.
The following data is part of a premarket notification filed by Semler Scientific, Inc. with the FDA for Quantaflo.
Pre-market Notification Details
| Device ID | K143094 |
| 510k Number | K143094 |
| Device Name: | QuantaFlo |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | SEMLER SCIENTIFIC, INC. 2330 NW EVERETT STREET Portland, OR 97210 |
| Contact | Bob Mcrae |
| Correspondent | Bob Mcrae SEMLER SCIENTIFIC, INC. 2330 NW EVERETT STREET Portland, OR 97210 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-28 |
| Decision Date | 2015-03-05 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859433006123 | K143094 | 000 |
| 00859433006079 | K143094 | 000 |
| 00859433006062 | K143094 | 000 |
| 00859433006048 | K143094 | 000 |
| 00859433006024 | K143094 | 000 |
Trademark Results [QuantaFlo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUANTAFLO 88274741 5827470 Live/Registered |
Semler Scientific, Inc. 2019-01-24 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.