510(k) K191697
K191697 is an FDA 510(k) premarket notification submitted by Zynex Medical, Inc. for the device "Cardiac Monitor 1500". The FDA issued a decision of Substantially Equivalent on February 21, 2020. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. Zynex Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 2020
- Date Received
- June 25, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plethysmograph, Impedance
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- CV
- Submission Type