FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Philips MR Patient Care Portal
K Number: K212227
·
Decision Sep 30, 2021
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
305
Applicant Total
29
Review Days
76
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Basic Information
- Device Name
- Philips MR Patient Care Portal
- K Number
- K212227
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Invivo Corporation
- Date Received
- July 16, 2021
- Decision Date
- September 30, 2021
- Product Code
- MWI
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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| K162177 | dS FootAnkle I6CH 1.5T Coil | Sep 14, 2016 | Substantially Equivalent |
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| K152330 | Expression MR400 MRI Patient Monitoring System | Dec 23, 2015 | Substantially Equivalent |
| K153073 | UroNav (Version 2.0) | Nov 16, 2015 | Substantially Equivalent |
| K133030 | DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) | Jan 22, 2014 | Substantially Equivalent |