FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇬 Singapore
Biovitals Analytics Engine
K Number: K183282
·
Decision Aug 15, 2019
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
7
Applicant Total
4
Review Days
262
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Basic Information
- Device Name
- Biovitals Analytics Engine
- K Number
- K183282
- 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
- November 26, 2018
- Decision Date
- August 15, 2019
- Product Code
- PLB
- 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 |
|---|---|---|---|
| PLB | Multivariate Vital Signs Index | FDA class 2 | Cardiovascular |
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