The following data is part of a premarket notification filed by Ascom Ums Srl Unipersonale with the FDA for Digistat Smart Central.
| Device ID | K180430 |
| 510k Number | K180430 |
| Device Name: | Digistat Smart Central |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | ASCOM UMS Srl Unipersonale Via Amilcare Ponchielli 29 Scandicci (fi), IT 50018 |
| Contact | Paolo Burchietti |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-16 |
| Decision Date | 2018-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350097870032 | K180430 | 000 |