The following data is part of a premarket notification filed by Ascom Sweden Ab with the FDA for Unite Connect For Clinical Systems.
| Device ID | K180566 |
| 510k Number | K180566 |
| Device Name: | Unite Connect For Clinical Systems |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | Ascom Sweden AB Grimbodalen 2 Goteborg, SE Se-402 76 |
| Contact | Ivan Liljegren |
| Correspondent | Thomas Kroenke Speed To Market, Inc. PO Box 3018 Nederland, CO 80466 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-05 |
| Decision Date | 2018-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350088671273 | K180566 | 000 |