FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ivWatch Model 400
K Number: K142374
·
Decision Feb 13, 2015
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
47
Applicant Total
6
Review Days
171
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Basic Information
- Device Name
- ivWatch Model 400
- K Number
- K142374
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ivwatch, LLC
- Date Received
- August 26, 2014
- Decision Date
- February 13, 2015
- Product Code
- MRZ
- 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 |
|---|---|---|---|
| MRZ | Accessories, Pump, Infusion | FDA class 2 | General Hospital |
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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 |
| K153605 | ivWatch Model 400 | Feb 11, 2016 | Substantially Equivalent |