The following data is part of a premarket notification filed by St. Jude Medical (now Part Of The Abbott Medical) with the FDA for Quantien Measurement System.
| Device ID | K172182 |
| 510k Number | K172182 |
| Device Name: | QUANTIEN Measurement System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | St. Jude Medical (now Part Of The Abbott Medical) One St.Jude Medical Device St. Paul, MN 55117 |
| Contact | Julie Dalquist |
| Correspondent | Julie Dalquist St. Jude Medical (now Part Of The Abbott Medical) One St.Jude Medical Device St. Paul, MN 55117 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-19 |
| Decision Date | 2017-08-18 |
| Summary: | summary |