The following data is part of a premarket notification filed by Semler Scientific, Inc. with the FDA for Quantaflo.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00859433006123 | K143094 | 000 |
00859433006079 | K143094 | 000 |
00859433006062 | K143094 | 000 |
00859433006048 | K143094 | 000 |
00859433006024 | K143094 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
QUANTAFLO 88274741 5827470 Live/Registered |
Semler Scientific, Inc. 2019-01-24 |