MY01 Continuous Compartmental Pressure Monitor
FDA 510(k) clearance K220952 · decided 2022-05-24
Clearance details
- K-number
- K220952
- Device name
- MY01 Continuous Compartmental Pressure Monitor
- Applicant
- MY01, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-04-01
- Decision date
- 2022-05-24
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- LXC
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Montreal, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.