The following data is part of a premarket notification filed by St. Jude Medical (now Abbott Medical) with the FDA for Quantien Measurement System.
| Device ID | K183099 |
| 510k Number | K183099 |
| Device Name: | QUANTIEN Measurement System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | St. Jude Medical (now Abbott Medical) One St. Jude Medical Drive St. Paul, MN 55117 |
| Contact | Ka Zoua Xiong |
| Correspondent | Ka Zoua Xiong St. Jude Medical (now Abbott Medical) One St. Jude Medical Drive St. Paul, MN 55117 |
| Product Code | DQK |
| Subsequent Product Code | DSK |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-07 |
| Decision Date | 2019-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067029997 | K183099 | 000 |
| 05415067030009 | K183099 | 000 |