ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable— 510(k) K192385
Substantially EquivalentIvwatch, LLC
FDA 510(k) clearance K192385 for ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable, Substantially Equivalent on 2020-07-02. Applicant: Ivwatch, LLC.
Clearance details
- Applicant
- Ivwatch, LLC
- Product code
- Code PMS
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newport News, VA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.