Ivwatch, LLC
Ivwatch, LLC appears in FDA public data with 0 recalls, 6 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent FDA inspection ended on Aug 25, 2017 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Mar 15, 2024.
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Summary
- Total Recalls
- 0
- 510(k) Clearances
- 6
- Inspections
- 1
- Compliance Actions
- 0
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 25, 2017 | Newport News, VA | Devices | No Action Indicated (NAI) | 3011490091 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K233881 | ivWatch® Model 400 | Mar 15, 2024 |
| K222212 | ivWatch Model 400 | Aug 24, 2022 |
| K192385 | ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable | Jul 2, 2020 |
| K162478 | ivWatch | Dec 22, 2016 |
| K153605 | ivWatch Model 400 | Feb 11, 2016 |
| K142374 | ivWatch Model 400 | Feb 13, 2015 |