FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ivWatch Model 400
K Number: K153605
·
Decision Feb 11, 2016
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
6
Review Days
56
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Basic Information
- Device Name
- ivWatch Model 400
- K Number
- K153605
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ivwatch, LLC
- Date Received
- December 17, 2015
- Decision Date
- February 11, 2016
- Product Code
- PMS
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PMS | Peripheral Intravenous (Piv) Infiltration Monitor | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PMS), ordered by most recent decision date.
ivWatch® Model 400
FDA 510(k)
FDA Class 2
·General Hospital
ivWatch Model 400
FDA 510(k)
FDA Class 2
·General Hospital
ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable
FDA 510(k)
FDA Class 2
·General Hospital
ivWatch
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Ivwatch, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K233881 | ivWatch® Model 400 | Mar 15, 2024 | Substantially Equivalent |
| K222212 | ivWatch Model 400 | Aug 24, 2022 | Substantially Equivalent |
| K192385 | ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable | Jul 2, 2020 | Substantially Equivalent |
| K162478 | ivWatch | Dec 22, 2016 | Substantially Equivalent |
| K142374 | ivWatch Model 400 | Feb 13, 2015 | Substantially Equivalent |