The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for The Clearsight Finger Cuffs.
Device ID | K190130 |
510k Number | K190130 |
Device Name: | The ClearSight Finger Cuffs |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
Contact | Christine J. Chun |
Correspondent | Christine J. Chun Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-01-28 |
Decision Date | 2019-06-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50690103199623 | K190130 | 000 |
50690103199616 | K190130 | 000 |
50690103199609 | K190130 | 000 |
50690103203344 | K190130 | 000 |
50690103203337 | K190130 | 000 |
50690103203320 | K190130 | 000 |