FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇬 Singapore
Everion+ System
K Number: K213863
·
Decision Feb 23, 2023
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
116
Applicant Total
4
Review Days
440
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Basic Information
- Device Name
- Everion+ System
- K Number
- K213863
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biofourmis Singapore Pte., Ltd.
- Date Received
- December 10, 2021
- Decision Date
- February 23, 2023
- Product Code
- MSX
- 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 |
|---|---|---|---|
| MSX | System, Network And Communication, Physiological Monitors | FDA class 2 | Cardiovascular |
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