sam X1 Long Duration Ultrasound Device— 510(k) K211513
Substantially EquivalentZetrOZ Systems, LLC
FDA 510(k) clearance K211513 for sam X1 Long Duration Ultrasound Device, Substantially Equivalent on 2021-08-18. 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
- Special
- Location
- Trumbull, CT, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.