ivWatch Model 400
FDA 510(k) clearance K153605 · decided 2016-02-11
Clearance details
- K-number
- K153605
- Device name
- ivWatch Model 400
- Applicant
- Ivwatch, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-12-17
- Decision date
- 2016-02-11
- Days to decision
- 56 days
- Clearance type
- Special
- Product code
- PMS
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Williamsburg, VA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ivWatch® Model 400 (K233881) | Ivwatch, LLC | 2024-03-15 |
| ivWatch Model 400 (K222212) | Ivwatch, LLC | 2022-08-24 |
| ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable (K192385) | Ivwatch, LLC | 2020-07-02 |
| ivWatch (K162478) | Ivwatch, LLC | 2016-12-22 |
Recalls involving this device
No recalls on record reference this clearance.