510(k) K251218
K251218 is an FDA 510(k) premarket notification submitted by SafeBeat Rx, Inc. for the device "SafeBeat Rx App". The FDA issued a decision of Substantially Equivalent on February 6, 2026. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 2026
- Date Received
- April 21, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type