510(k) K193321
K193321 is an FDA 510(k) premarket notification submitted by MY01, Inc. for the device "MY01 Continuous Compartmental Pressure Monitor". The FDA issued a decision of Substantially Equivalent on July 30, 2020. The device falls under product code LXC (Monitor, Pressure, Intracompartmental), a Class U device. MY01, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2020
- Date Received
- December 2, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Pressure, Intracompartmental
- Device Class
- Class U
- Regulation Number
- Review Panel
- OR
- Submission Type