FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Zynex Monitoring System, Model CM-1600
K Number: K223217
·
Decision Jun 16, 2023
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
113
Applicant Total
5
Review Days
242
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Basic Information
- Device Name
- Zynex Monitoring System, Model CM-1600
- K Number
- K223217
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zynex Medical, Inc.
- Date Received
- October 17, 2022
- Decision Date
- June 16, 2023
- Product Code
- DSB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSB | Plethysmograph, Impedance | FDA class 2 | Cardiovascular |
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