sam 2.0 Long Duration Ultrasound System— 510(k) K191568
Substantially EquivalentZetrOZ Systems, LLC
FDA 510(k) clearance K191568 for sam 2.0 Long Duration Ultrasound System, Substantially Equivalent on 2020-03-06. Applicant: ZetrOZ Systems, LLC.
Clearance details
- Applicant
- ZetrOZ Systems, LLC
- Product code
- Code PFW
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Trumbull, CT, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.