Zynex Monitoring System, Model CM-1600
FDA 510(k) clearance K223217 · decided 2023-06-16
Clearance details
- K-number
- K223217
- Device name
- Zynex Monitoring System, Model CM-1600
- Applicant
- Zynex Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-10-17
- Decision date
- 2023-06-16
- Days to decision
- 242 days
- Clearance type
- Traditional
- Product code
- DSB
- Device class
- 2
- Regulation number
- 870.2770
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.