510(k) K212622
K212622 is an FDA 510(k) premarket notification submitted by Zyter, Inc. for the device "Zyter RPM". The FDA issued a decision of Substantially Equivalent on February 11, 2022. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 2022
- Date Received
- August 18, 2021
- 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