The following data is part of a premarket notification filed by Radi Medical Systems Ab with the FDA for Quantien Measurement System.
| Device ID | K123984 |
| 510k Number | K123984 |
| Device Name: | QUANTIEN MEASUREMENT SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
| Contact | Anna-lisa Tiensuu |
| Correspondent | Anna-lisa Tiensuu RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2013-03-28 |
| Summary: | summary |