Cardiac Monitor 1500— 510(k) K191697
Substantially EquivalentZynex Medical, Inc.
FDA 510(k) clearance K191697 for Cardiac Monitor 1500, Substantially Equivalent on 2020-02-21. Applicant: Zynex Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Zynex Medical, Inc.
- Product code
- Code DSB
- Device class
- Class 2
- Regulation
- 21 CFR 870.2770
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Englewood, CO, US
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