510(k) K261287
K261287 is an FDA 510(k) premarket notification submitted by Ascom Ums Srl Unipersonale for the device "Digistat Care". The FDA issued a decision of Substantially Equivalent on September 12, 2026. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Ascom Ums Srl Unipersonale has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 2026
- Date Received
- April 20, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Network And Communication, Physiological Monitors
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type